Cold Compression Wrap Pro
Device Facts
| Record ID | K230524 |
|---|---|
| Device Name | Cold Compression Wrap Pro |
| Applicant | Chengdu Cryo-Push Medical Technology Co.,Ltd |
| Product Code | IRP · Physical Medicine |
| Decision Date | Jan 19, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Device Story
Cold Compression Wrap Pro consists of main unit and inflatable wraps (shoulder, elbow/arm, lower limbs, ankle/foot) containing cold packs. Device operates by inflating/deflating air chambers to simulate kneading and stroking of tissues; provides intermittent compression (5 intensity settings, 20-100 mmHg) and localized cold therapy (-18°C to -4°C). Used in clinics, hospitals, and athlete training environments; operated by clinicians or patients. Output is mechanical pressure and cold temperature application. Benefits include temporary relief of minor muscle aches/pains and increased circulation in treated areas.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification/validation, and internal performance testing (appearance, size, wrap performance, function).
Technological Characteristics
Materials: Nylon with PVC laminate. Principle: Intermittent pneumatic compression (0-100 mmHg) and cold pack therapy. Energy: 100-240V AC. Form factor: Main unit with 4 wrap types. Connectivity: None. Software: Embedded system, moderate level of concern. Sterilization: Not specified.
Indications for Use
Indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation in healthy individuals. Simulates kneading and stroking of tissues via inflatable wrap. Cold pack indicated for localized cold therapy.
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
- Cryopush Cold Compression Device (K222669)
- Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC Use (K133483)
Submission Summary (Full Text)
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January 19, 2024
Chengdu Cryo-Push Medical Technology Co.,Ltd % Liz Li Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K230524
Trade/Device Name: Cold Compression Wrap Pro Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: October 31, 2023 Received: November 20, 2023
Dear Liz Li:
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).
Sincerely,
# Tushar Bansal -S
for Heather Dean, PhD 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) K230524
Device Name Cold Compression Wrap Pro
#### Indications for Use (Describe)
The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in created areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary K230524
## 1. Contact Details
1.1 Applicant information
| 510(k) owner's name | Chengdu Cryo-Push Medical Technology Co.,Ltd |
|---------------------|-------------------------------------------------------|
| Address | 102, 105, Zone 20, Huayin Industrial Port, No.618, |
| | Kexing Road (West), Wenjiang District, Chengdu 611137 |
| | Sichuan P.R.China |
| Phone No. | TEL: +86 18086852687 |
| Fax No. | / |
| Name of contact | Zhang Peiyong |
| person | |
| Date Prepared | Nov.18th.2023 |
| | |
#### 1.2 Submission Correspondent
| 卓远天成 | Shenzhen Joyantech Consulting Co., Ltd. |
|----------------|--------------------------------------------------------|
| | 1713A, 17th Floor, Block A, Zhongguan Times Square, |
| | Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, |
| | Guangdong Province, China |
| Phone No. | +86 755-86069197 |
| Contact person | Liz Li |
| e-mail | liz@cefda.com; grace@cefda.com |
| Website | http://www.cefda.com |
### 2. Device information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Trade name | Cold Compression Wrap Pro |
|---------------------|-----------------------------------|
| Classification | II |
| Classification name | Massager, Powered Inflatable Tube |
| Product code | IRP; IME |
| Regulation No. | 21 CFR 890.5650 |
### 3. Legally Marketed Predicate Device
| Trade Name | Cryopush Cold Compression Device |
|----------------|----------------------------------|
| Classification | II |
| 510(k) Number | K222669 |
| Product Code | IRP; IME |
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| Manufacturer | Chengdu Cryo-Push Medical Technology Co., Ltd |
|---------------|----------------------------------------------------------------------------------------|
| Trade Name | Portable Therapeutix Squid Active Cold Compression<br>device and Cold Pack for OTC Use |
| 510(k) Number | K133483 |
| Product Code | IRP, IME |
| Manufacturer | MEDIcept, Inc. |
### 4. Device Description
Cold Compression Wrap Pro Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient.
There are 4 different wraps for Shoulder, elbow/arm, low limbs (Calf and upper leg), ankle/foot. The wrap contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the device is used for 30 minutes (Default time) at the operature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18°C ~-4℃) (±2℃).
### 5. Intended use
The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.
The cold wrap is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
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# 6. Substantial Equivalence Comparison
| Item | Subject device | Predicate device K222669 | Predicate device K133483 | Comments |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device name | Cold Compression Wrap Pro | Cryopush Cold Compression<br>Device | Portable Therapeutix Squid<br>Active Cold Compression<br>device and Cold Pack for<br>OTC Use | / |
| model | A02-C-006 | A02-P-001 | not publicly available | / |
| Regulation number | 21 CFR 890.5650,<br>21 CFR 890.5700 | 21 CFR 890.5650,<br>21 CFR 890.5700 | 21 CFR 890.5650,<br>21 CFR 890.5700 | Identical |
| Classification | II | II | II | Identical |
| Product Code | IRP, IME | IRP, IME | IRP, IME | Identical |
| Intended use | The Cold Compression Wrap<br>Pro is indicated for the<br>temporary relief of minor<br>muscle aches and pains.<br>The device is indicated for<br>temporary increase in<br>circulation of the treated<br>areas in people who are in<br>good health, and simulates<br>kneading and stroking of<br>tissues using an inflatable<br>wrap.<br>The cold pack is indicated for<br>localized therapy in situations<br>where cold temperature<br>therapy is necessary or<br>desirable. | The Cryopush Cold<br>Compression Device is<br>indicated for the temporary<br>relief of minor muscle aches<br>and pains.<br>The device is indicated for<br>temporary increase in<br>circulation of the treated<br>areas in people who are in<br>good health, and simulates<br>kneading and stroking of<br>tissues using an inflatable<br>wrap.<br>The cold pack is indicated for<br>localized therapy in situations<br>where cold temperature<br>therapy is necessary or<br>desirable. | The Squid Active Cold<br>Compression device and Cold<br>Pack for OTC use is indicated<br>for the temporary relief of<br>minor muscle aches and<br>pains.<br>The compression device is<br>indicated for temporary<br>increase in circulation of the<br>treated areas in people who<br>are in good health, and<br>simulates kneading and<br>stroking of tissues using an<br>inflatable garment.<br>The cold pack is indicated for<br>localized therapy in situations<br>where cold temperature<br>therapy is necessary or<br>desirable. | Identical |
| Item | Subject device | Predicate device K222669 | Predicate device K133483 | Comments |
| Treatment area/<br>Structure of<br>Sleeves | Shoulder, elbow/arm, low<br>limbs (Calf and upper leg),<br>ankle/foot | Low limbs (Calf and upper<br>leg) | Leg, foot, arm, shoulders,<br>lower back, hands | Note |
| OTC or Rx | OTC | OTC | OTC | Identical |
| Environment of<br>Use | Clinics, hospital, athlete<br>training environments | Clinics, hospital, athlete<br>training, and home<br>environments | not publicly available | Note |
| Power source | 100-240V~50/60Hz | 100-240V~50/60Hz | 120V 60 Hz, consumption<br>26W; AC adapter: 120V 60<br>Hz, consumption 36W Lithium<br>battery | Identical to<br>K222669 |
| Principle of<br>operation/<br>Mechanical<br>characteristics | Intermittent compression 5<br>intensity settings<br>1-20 mmHg<br>2-40 mmHg<br>3-60 mmHg<br>4-80 mmHg<br>5-100 mmHg | Intermittent compression 5<br>intensity settings<br>1-20 mmHg<br>2-40 mmHg<br>3-60 mmHg<br>4-80 mmHg<br>5-100 mmHg | Intermittent compression 4<br>intensity settings<br>1-30 mmHg<br>2-50 mmHg<br>3-70 mmHg<br>4-85 mmHg | Identical to<br>K222669 &<br>Note |
| Working Time | 10min, 20 min, 30 min, 40<br>min, 50 min, 60 min, 70 min,<br>80 min, 90 min, 100 min, 110<br>min, 120 min, default as<br>30min | 10min, 20 min, 30 min, 40<br>min, 50 min, 60 min, 70 min,<br>80 min, 90 min, 100 min, 110<br>min, 120 min, default as<br>30min | 15min | Identical to<br>K222669 |
| Pressure range | 0-100mmHg | 0-100mmHg | 0-85mmHg | Identical to<br>K222669 |
| Pressure levels | 20mmHg,40 mmHg,60<br>mmHg,80 mmHg,100 mmHg. | 20mmHg,40 mmHg,60<br>mmHg,80 mmHg,100 mmHg. | 30mmHg,40 mmHg,70<br>mmHg,85 mmHg | Identical to<br>K222669 |
| Pressure error<br>range | ±15mmHg | ±15mmHg | not publicly available | Identical to<br>K222669 |
| Keep time | 5s | 10s | not publicly available | Substantial |
| Deflation time | 6s | 20s | not publicly available | Equivalence |
| Item | Subject device | Predicate device K222669 | Predicate device K133483 | Comments |
| Noise level | ≤ 55dB | ≤ 55dB | not publicly available | Identical to<br>K222669 |
| Wrap Material | Nylon with a PVC laminate | Nylon with a PVC laminate | Nylon with TPU backing<br>wrap-yes | Identical to<br>K222669 |
| Patient contact | Non-conductive attachments | Non-conductive attachments | not publicly available | Identical to<br>K222669 |
| Single Wrap<br>weight | low limbs (Calf and upper<br>leg):480g;<br>Ankle/foot: 338g;<br>Shoulder: 388g;<br>elbow/arm: 308g; | 480g | not publicly available | |
| Wrap Size | low limbs (Calf and upper<br>leg): 330*610mm;<br>Ankle/foot: 830*420mm;<br>Shoulder: 1080*430mm;<br>elbow/arm: 620*440mm; | 330*610mm | not publicly available | Substantial<br>Equivalence |
| Cold pack weight | low limbs (Calf and upper<br>leg):1030g;<br>Ankle/foot: 1282g;<br>Shoulder: 932g;<br>elbow/arm: 632g; | 1030g (±10%) | not publicly available | |
| Cold pack Size | low limbs (Calf and upper<br>leg):570*300mm;<br>Ankle/foot: 595*260mm;<br>Shoulder: 520*360mm;<br>elbow/arm: 440*370mm; | 300*570mm | not publicly available | |
| Cold pack<br>Operating<br>temperature | -18℃~-4°C (±2°C) | -18℃~-4℃ (±2℃) | not publicly available | Identical to<br>K222669 |
| Operating<br>environment | Temperature:<br>5℃~ 40℃ (41°F ~ 104°F)<br>Relative humidity: | Temperature:<br>5℃~ 40℃(41°F ~ 104°F)<br>Relative humidity: | not publicly available | Identical to<br>K222669 |
| Item | Subject device | Predicate device K222669 | Predicate device K133483 | Comments |
| Transportation &<br>Storage<br>environment | 10% ~ 90%<br>Atmospheric pressure:<br>700~1060hpa | 10% ~ 90%<br>Atmospheric pressure:<br>700~1060hpa | | |
| | Temperature: | Temperature: | | |
| | -25℃~55℃ (-13°F~131°F) | -25℃~55℃ (-13°F~131°F ) | | |
| | Relative humidity:<br>10% ~ 90%<br>Atmospheric pressure:<br>700~1060hpa | Relative humidity:<br>10% ~ 90%<br>Atmospheric pressure:<br>700~1060hpa | not publicly available | Identical to<br>K222669 |
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#### Product: Cold Compression Wrap Pro
#### Chengdu Cryo-Push Medical Technology Co., Ltd
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The subject device, Cold Compression Wrap Pro, is substantially equivalent to the predicate device K222669 and K133483. This conclusion is based upon comparison on intended use, principle of operation and technological characteristics, etc.
### 7. Summary of Non-clinical Performance Testing
The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility 1)
- -IEC 60601-1:2005, AMDI:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- 2) Software validation
The subject device contains an embedded software system. Software verification and validation testing were conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the software for this device was considered as a "moderate" level of concern.
- 3) Performance
There are no FDA recognized consensus standards for this device. We tested the following items according to our internal standards,
- -Product Appearance and Size
- -Wrap Performance
- -Function Test
- 4) Biocompatibility test
The subject device and the predicated device use the same patient contact material, and has the same nature of body contact and contact duration. Therefore, no biocompatibility test was conducted.
#### 8. Clinical testing
N/A
#### 9. Conclusions
The subject device, Cold Compression Wrap Pro, is substantially equivalent to the predicate device K222669 and K133483. This conclusion is based upon comparison on intended use, principle of operation and technological characteristics, etc.
