Air Pressure Therapy System (Model:VU-IPC4M)
Device Facts
| Record ID | K233238 |
|---|---|
| Device Name | Air Pressure Therapy System (Model:VU-IPC4M) |
| Applicant | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Product Code | IRP · Physical Medicine |
| Decision Date | Jun 14, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Air Pressure Therapy System (Model:VU-IPCAM) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Device Story
Air Pressure Therapy System (Model: VU-IPC4M) is a home-use powered inflatable tube massager. It consists of an air pump, air pressure sensor, microprocessor, and inflatable sleeves (leg, arm, hip, or pant styles). The device operates by sequentially inflating and deflating air chambers within the sleeves to simulate kneading and stroking of tissues, moving from the limb end toward the body center. The user controls the device via a hand controller or mobile app (Bluetooth). The microprocessor manages inflation cycles, pressure levels, and timing based on selected modes. By providing graduated compression, the device aims to relieve minor muscle aches and pains and improve local circulation. The system includes safety features to prevent over-pressurization and ensures biocompatibility of sleeve materials.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2), battery safety (IEC 62133-2), biocompatibility (ISO 10993-5, ISO 10993-10), wireless coexistence (ANSI C63.27), pressure/time accuracy, seam strength, and software failure mode verification.
Technological Characteristics
Powered inflatable tube massager; 4-chamber design; molded ABS enclosure; 11.1V/1600mAh Li-ion battery; sleeves made of nylon cloth and polyether amine; microprocessor-controlled pneumatic system; Bluetooth connectivity; sterilization not specified; software-controlled inflation sequences.
Indications for Use
Indicated for healthy individuals for temporary relief of minor muscle aches/pains and temporary increase in circulation to treated areas (leg, arm, hip, back).
Regulatory Classification
Identification
A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
Predicate Devices
- RecoveryAir PRO (K211745)
- Compressible Limb and Circulation Therapy System (K211283)
- V12 PRO (K210913)
Submission Summary (Full Text)
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June 14, 2024
Xiamen Weiyou Intelligent Technology Co., Ltd. % Libray Chang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No. 133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K233238
Trade/Device Name: Air Pressure Therapy System (Model: VU-IPC4M) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 23, 2024 Received: May 23, 2024
Dear Libray Chang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Heather L. Dean -S
Heather Dean, Ph.D Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known) K233238
Device Name
Air Pressure Therapy System (Model: VU-IPC4M)
Indications for Use (Describe)
Air Pressure Therapy System (Model:VU-IPCAM) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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| Type of Submission | Traditional |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | June 11, 2024 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 3 No. 6 Xianghong Road, Torch Hi-Tech Zone<br>Industrial Park, Xiang'an District, Xiamen P.R.China. |
| Tel | 086-0592-6251545 |
| Email | 17916220@qq.com |
| Contact Person | Yong Sun |
| Device Identification | |
| Trade Name | Air Pressure Therapy System (Model:VU-IPC4M) |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Powered inflatable tube massager |
| Device Classification | Class II |
| Product Code | IRP |
| Panel | Physical Medicine |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China |
| Tel | 86-13020102321 |
| Email | Libray@spicagloble.com |
| Contact Person | Libray Chang |
| Indications for Use | |
| | Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minor<br>muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who |
#### Device Description
are in good health.
Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves
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Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
#### Predicate and Reference Device Information
| Predicate (Primary): | THERAGUN, Inc. |
|------------------------|--------------------------------------------------|
| Trade/Device Name | RecoveryAir PRO |
| 510(K) number | K211745 |
| Predicate (Secondary): | Wonjin Mulsan Co., Ltd. |
| Trade/Device Name | Compressible Limb and Circulation Therapy System |
| 510(K) number | K211283 |
| Predicate (Tertiary): | SLK Medical GmbH |
| Trade/Device Name | V12 PRO |
| 510(K) number | K210913 |
#### Performance Testing - Clinical
Not Applicable.
#### Performance Testing - Animal
Not Applicable.
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# Table 6A: Summary of Comparison
| | Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate | Differences<br>Discussion |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Air Pressure Therapy<br>System<br>(Model:VU-IPC4M) | RecoveryAir PRO (Model<br>RecoveryAir PRO) | Compressible Limb and<br>Circulation Therapy System | V12 PRO | N/A |
| 510(k) number | K233238 | K211745 | K211283 | K210913 | N/A |
| Manufacturer | Xiamen<br>Weiyou<br>Intelligent Technology<br>Co., Ltd. | Theragun Inc | Wonjin Mulsan Co., Ltd. | SLK Medical<br>GmbH | N/A |
| Product<br>regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification<br>name | Massager, Powered<br>Inflatable Tube | Massager, Powered Inflatable<br>Tube | Massager, Powered Inflatable<br>Tube | Massager, Powered<br>Inflatable Tube | Same |
| Regulation class | 2 | 2 | 2 | 2 | Same |
| Product code | IRP | IRP | IRP | IRP | Same |
| Indications for<br>use | Air Pressure Therapy<br>System<br>(Model: VU-IPC4M) is<br>intended for home to<br>temporarily relieve<br>minor muscle aches<br>and/or pains, and to<br>temporarily increase | The RecoveryAir PRO is an<br>air compression therapy<br>device intended to provide<br>graduated pressure to<br>compression garments.<br>The RecoveryAir PRO is<br>indicated for the temporary<br>relief of minor muscle aches | POWER-Q2300 is intended<br>for the temporary relief of<br>minor muscle aches and<br>pains, and for temporary<br>increase in blood circulation<br>to the treated areas in people<br>who are in good health.<br>POWER-Q2300 simulates | V12 PRO is a<br>Compression<br>Therapy System is<br>intended for the<br>temporary relief of<br>minor muscle aches<br>and pains and for<br>the temporary | Same |
| Rx or OTC | | | | | |
| | circulation to the<br>treated areas in people<br>who are in good health. | and pains, and for temporary<br>increase in blood circulation<br>to the treated areas in people<br>who are in good health.<br>The RecoveryAir PRO<br>simulates kneading and<br>stroking of tissues by using<br>an inflatable garment. | kneading and stroking of<br>tissues by using an inflatable<br>garment (cuff). | increase in<br>circulation to the<br>treated areas in<br>people who are in<br>good health.<br>The V12 PRO<br>Therapy System<br>simulates kneading<br>and stroking of<br>tissues by using an<br>inflatable garment. | Same |
| Rx or OTC | OTC | OTC | OTC | OTC | Same |
| Power Source | 11.1 V / 1600mAh<br>Rechargeable Li-ion<br>battery (100-240V AC<br>input) | 100-240V AC, 50/60 Hz,<br>12V or internal battery | 110-120VAC, 50/60Hz | 110-230V 50/60 Hz | Similar |
| Dimensions<br>(W*H*L) | 25.42*6.03*6.92CM | 8.6in (L) *6.7in (W) *5.1in<br>(H) | 290 x 260 x 172 mm | 6.69"x 7.87"x7.87" | Similar |
| Weight | 0.58 kg | 4.202 pounds | 3.1 kg | 4.4 pounds | Similar |
| Housing<br>Materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS<br>enclosure | Same |
| Number of<br>Chambers | 4-chamber | 4-chamber | 4 Chambers | 12 Chambers | Similar |
| Sleeve Materials | Nylon cloth +PUether<br>amine | Polyether Nylon Fabric | / | Nylon with a<br>Polyurethane<br>laminate | Different |
| Modes | Mode A: In this mode | Sequential, ISO or Rehab | Mode A: | Inflates chambers | Different. |
| ((Inflation<br>sequences)) | | (wave), Flow cycles | | | |
| | ①chamber is inflated<br>and the pressure is<br>maintained after filling;<br>②chambers are<br>inflated, chambers are<br>inflated and ①<br>chamber is deflated<br>while maintaining<br>pressure after filling;<br>Similarly, the pressure<br>is maintained after ③<br>chambers are filled, ④<br>chambers are inflated,<br>and ② chambers are<br>deflated; Then the cycle<br>repeats. | Sequential mode that applies<br>a directional massage,<br>starting at the base of the<br>treated area, and progresses<br>upwards towards the torso<br>and then releases<br><br>ISO mode that applies a<br>directional massage to a<br>smaller, user selected area.<br>The first chamber inflates,<br>and after a few seconds, the<br>second chamber starts to<br>inflate until both chambers<br>reach the set pressure. Then<br>both chambers deflate,<br>and after a pause the process<br>starts again<br><br>Wave mode: The first<br>chamber inflates, and after a<br>few seconds, the 1st and 2nd<br>chamber starts to inflate until<br>both chambers<br>reach the set pressure. Then | Image: Mode B | from bottom up but<br>maintains pressure<br>in lower chambers<br>as works its way to<br>top. Then all<br>chambers release<br>pressure at same<br>time once all<br>chambers have<br>sequentially<br>inflated.<br>Sequential | Although the<br>subject device<br>provides 7 kinds<br>of work mode,<br>the Mode A and<br>Mode B are the<br>same with<br>Sequential, ISO<br>or Rehab (wave)<br>of Primary<br>predicate device<br>(K211745), while<br>the other work<br>modes of subject<br>device just have<br>difference about<br>inflatable order of<br>the different<br>chambers. The<br>treatment<br>pressure range are<br>the same under<br>different work<br>modes, so the<br>difference of<br>pressure range<br>would not raise |
| | Mode B: In this mode,<br>①chamber is inflated<br>and the pressure is<br>maintained after filling;<br>②chamber inflation;<br>the same as ③chamber<br>and ④chamber; Then<br>the cycle repeats. | | Image: Mode C | | |
| | Mode C: In this mode, | | Image: Mode D | | |
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| the four chambers are | the deflation on 1st chamber , | | adversely impact |
|---------------------------|---------------------------------------------------------------------------------|--|------------------|
| inflated at the same | the 2nd and 3rd chambers | | on safety and |
| time, the pressure is | starts to inflate until the both | | effectiveness. |
| maintained after filling, | chambers reach the set | | |
| and then the four | pressure; then deflate the 2nd | | |
| chambers are deflated | chambers inflate 3rd and 4th | | |
| at the same time;After | chambers until the both | | |
| deflation, the four | chambers reach the set | | |
| | pressure | | |
| chambers are inflated at | | | |
| the same time;Then the | Flow cycles | | |
| cycle repeats. | Progress 1: first inflate | | |
| | Chamber 1 to target pressure,<br>then hold & release. then go<br>to Progress 2. | | |
| Mode D: In this mode, | Progress 2: first inflated | | |
| only a single chamber | Chamber 1 to target pressure, | | |
| is inflated at a time. | theninflate Chamber 2 and | | |
| Starting from the | hold Chamber 1. when | | |
| chamber① and | Chamber 2 reach the target | | |
| working up to the | pressure, hold chamber 1 & 2 | | |
| chamber④. Then the | for specified time, then | | |
| cycle repeats. | release totally, then go to | | |
| | Progress 3 | | |
| Mode E: in this mode. | Progress 3: first inflated | | |
| ①③are inflated,then | Chamber 1 to target pressure, | | |
| defalted, chamber ② | then inflate Chamber 2 and | | |
| ④are inflated,then | | | |
| deflated;Then the cycle | | | |
| repeats. | | | |
| | | | |
| Mode F: in this mode. | hold Chamber 1. when | | |
| ①② are inflated, then | Chamber 2 reach the target | | |
| defalted, chamber ③ | pressure, hold chamber 1 & | | |
| ④ are inflated, then | 2, & start to inflate | | |
| deflated; Then the cycle | Chamber 3, when Chamber 3 | | |
| repeats. | reach to the target pressure, | | |
| | then hold chamber 1, 2, 3 for | | |
| | specified time then release | | |
| ModeG: In this mode, | totally. Then go to Progress 4 | | |
| chamber 1 inflates to | Progress 4: first inflated | | |
| set pressure, it pulses | Chamber 1 to target pressure, | | |
| and holds pressure; | then inflate Chamber 2 and | | |
| Chamber 2 inflates to | hold Chamber 1. when | | |
| set pressure, pulses and | Chamber 2 reach the target | | |
| holds pressure, | pressure, hold chamber 1 & | | |
| chamber 1 is holding | 2, & start to inflate | | |
| pressure at the same | Chamber 3, when Chamber 3 | | |
| time; Chamber 3 | reach to the target pressure, | | |
| inflates to set pressure, | then hold chamber 1, 2, 3,& | | |
| pulses and holds | start to inflate Chamber 4, | | |
| pressure, chamber 1 & | when Chamber 4 reach to the | | |
| 2 are holding pressure | target pressure, then hold | | |
| at the same time; While | chamber 1, 2, | | |
| chamber 1 is | 3 &4 for specified time then | | |
| deflating, chamber 4 | release totally. then go back | | |
| inflates to set pressure, | to Progress 1 again. | | |
| pulses and holds | | | |
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Image /page/11/Figure/3 description: The image shows different modes of operation for a compression device. The modes include sequential cycle mode, sequential rehab (wave), wave cycle mode, and ISO cycle mode. The image also shows different programs (A, B, D, E, and F) with different patterns of chamber inflation and deflation.
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| | Flow cycles | | | | |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Image: Flow cycle mode | | | | |
| | | | | | |
| Anatomical site | Leg (including of foot,<br>calf, knee, upper leg)<br>Pants (including of<br>upper leg, glutes, hips,<br>lower back)<br>Arm (including of<br>entire arm, shoulder)<br>Half-Leg (including of<br>foot, calf, knee) | RecoveryAir Compression<br>Boots: 95*28.7 cm | Leg (including of foot, calf,<br>knee, upper leg)<br>Hip (including of upper leg,<br>glutes, hips, lower back)<br>Arm (including of entire arm,<br>shoulder)<br>Half-Leg (including of foot,<br>calf, knee) | Leg (consisting of<br>foot, calf, knee,<br>upper leg) Pant<br>(consists of foot,<br>calf, knee, upper<br>leg, glutes, hips,<br>lower back)<br>Arm (consisting of<br>entire arm,<br>shoulder, upper<br>chest and back)<br>Jacket (consisting of<br>entire arms,<br>shoulder, upper<br>chest and<br>back) | Similar |
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510(k) Summary K233238
Image /page/13/Figure/1 description: The image shows a comparison of different types of compression cuffs and pants. On the left, there are two sets of leg cuffs and a pair of pants, labeled with "Appearance and size of Cuffs". In the middle, there is a leg cuff with dimensions "Medium: 310x940mm" and "Large: 390x990", along with measurements of 310 and 940. On the right, there is a leg cuff with dimensions "32" x 30"", a pant, and the word "Similar".
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Image /page/14/Figure/1 description: The image shows a collection of medical compression garments. There are pants, arm sleeves, a waist wrap, hip wraps, and a jacket. Some of the items have dimensions listed, such as the arm sleeves which are available in medium (255x870mm) and large (330x895mm).
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| Image: black sleeve | | Half-Leg<br>Image: Half-Leg device with dimensions 300 and 700<br>300x700mm | | | |
|-----------------------|------------|-----------------------------------------------------------------------------|-------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Pressure range | 30~180mmHg | 20-100mmHg | 20-200 mmHg | 15-80 mmHg | Similar to<br>K211283,<br>Although the<br>pressure value is<br>different from<br>that of the<br>Primary Predicate<br>and Tertiary<br>Predicate, it is<br>included in the<br>pressure value<br>range of the<br>Secondary |
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| | | | | | | | Predicate, so the<br>pressure value of<br>the Subject<br>Device can be<br>proven to not<br>affect its safety<br>and effectiveness |
|----------------|---------------------|------------|---------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Time | Default<br>Settings | 30min, APP | 10min-90min, step of 5min | User can select operation<br>time from 15 and 30 minutes. | User determines<br>therapy time. Choose<br>from 15 to 60<br>minutessession<br>time. | | Different,<br>Although the<br>treatment time<br>range of subject<br>device is set by<br>APP, but the<br>default value is<br>30min which is<br>included in the<br>range of the<br>comparison<br>equipment. In the<br>process of use,<br>the user can start<br>or stop the button<br>on the hand<br>controller at any<br>time, so the<br>difference of<br>Treatment time |
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| | | | | | would not raise<br>adversely impact<br>on safety and<br>effectiveness. |
|--------------------------------------------------|-------------------------------------------------------------…
