NeoWave Pain Relief and Recovery System, Model# T16-2020
Device Facts
| Record ID | K202693 |
|---|---|
| Device Name | NeoWave Pain Relief and Recovery System, Model# T16-2020 |
| Applicant | Eva Medtec, Inc. |
| Product Code | IRP · Physical Medicine |
| Decision Date | Mar 5, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
Device Story
NeoWave Pain Relief and Recovery System is a gradient, sequential, pneumatic compression device; intended for temporary relief of minor muscle aches/pains and increased circulation in healthy individuals. System comprises air compressor, valve module(s), and therapy attachments (cushions) with 8 or 16 inflatable air channels. Operated by user in home or clinical environment. Device uses timed, pre-programmed air pressure to inflate/deflate channels sequentially (distal to proximal) to simulate human hand kneading/stroking. User adjusts pressure levels and session duration (15-30 mins). Microprocessor controls inflation cycles (3-5 seconds per chamber). Output is mechanical massage sensation. Benefits include muscle pain relief and improved local circulation. Safety features include user-accessible pause/stop button.
Clinical Evidence
Bench testing only. No clinical data. Evidence includes electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, -10), shipping/packaging (ASTM D4169-16), mechanical bench testing of assemblies, and a summative usability study confirming mitigation of usability risks.
Technological Characteristics
Powered inflatable tube massager; 12V DC power; sequential pneumatic compression. Materials: Nylon/polyurethane laminate (cushions), Polyester/spandex/PU film (covers), ABS/PC (enclosure). 8 or 16 air channels. Microprocessor-controlled inflation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, ISO 10993-5, ISO 10993-10. Non-sterile.
Indications for Use
Indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation in healthy individuals. Used via inflatable air channels to simulate kneading and stroking of tissues.
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
- Relaxor Perfect Touch Air Massaging System (K030437)
Submission Summary (Full Text)
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March 5, 2021
Eva Medtec, Inc Irene Waldridge Chief Technology Officer/Director of the Board 6300 W. Old Shakopee Road. Suite 140 Bloomington, Minnesota 55438
Re: K202693
Trade/Device Name: NeoWave Pain Relief and Recovery System, Model# T16-2020 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: October 16, 2020 Received: October 19, 2020
Dear Irene Waldridge:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices 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) K202693
Device Name
NeoWave Pain Relief and Recovery System, Model# T16-2020
#### Indications for Use (Describe)
The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
| 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) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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# SECTION 5: 510(K) SUMMARY
## 1. Submitter:
Eva Medtec, Inc. 6300 W. Old Shakopee Road, Suite 140 Bloomington. MN 55438 Contact Person: Irene Waldridge, Chief Technology Officer and Chairman of the Board Date Prepared: October 16, 2020
## 2. Device:
Name of Device: NeoWave Pain Relief and Recovery System, Model# T16-2020 Common or Usual Name: Powered Inflatable Tube Massager Classification Name: Massager, Powered Inflatable Tube (21 CFR 890.5650) Requlatory Class: II Product Code: IRP
## 3. Predicate Device:
Relaxor Perfect Touch Air Massaging System Applicant: Salton, Inc. (Washington, DC) 510(k) Number: K030437
## 4. Device Description:
The NeoWave Pain Relief and Recovery System Model # T16-2020 is a reusable, nonsterile therapy device intended to provide a gentle, rhythmic, soothing sensation using timed, pre-programed air pressure to inflate and deflate air channels within the therapy attachments. Each air channel inflates then deflates one at a time, to simulate the press and release action of the human hand by manipulating the soft tissues of the body relieving pain and increasing circulation.
This device is a gradient, sequential, pneumatic compression device intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
The NeoWave Pain Relief and Recovery System consists of an air compressor, valve module(s) and a therapy attachment working together as one unit. The therapy attachments contain one or two valve modules that connect to the Controller Unit via a
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series of receptacles, tubing, and cabling. The system uses an external power supply of 12V DC.
The Therapy Attachments/Cushions consist of inflatable welded pads with 8 or 16 air channels. The massage direction is distal to proximal (toward the heart). The sequential inflation cycle inflates then deflates one air channel at a time, for 3, 4 or 5 seconds allowing the user/patient to adjust the pressure. The therapy attachment/cushion works under the action of the valve module sensor and microprocessor.
## 5. Indications for Use:
The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
The Indications for Use statement for the NeoWave Pain Relief and Recovery System is identical to the predicate device.
## 6. Summary of Comparison of Technology Characteristics:
Powered inflatable tube massager is the technological principle for both the subject and the predicate devices. It is based on the use of inflating/deflating tubes/channels within a garment or attachment with air. Both devices simulate the kneading and stroking of tissues with the hands by use of an inflation pressure cuff.
The technology characteristics of the NeoWave system, e.g., overall device design, materials, mechanism of action, mode of operation, performance characteristics, intended use and type of use (reusable) is substantially equivalent to the predicate device; Relaxor Perfect Touch Air Massaging System.
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# Summary Table of Device Comparison
| Table 12<br>Parameter | Device Comparison | | Comparison |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Subject Device | Predicate Device | |
| | EVA MEDTEC, INC. | SALTON, INC. | N/A |
| 510(K)<br>Number | K202693 | K030437 | N/A |
| Model Name | NeoWave System T16-2020 | Relaxor Perfect Touch Air<br>Massaging System | N/A |
| Classification | Class II Device, IRP (21 CFR890.5650) | | Same |
| Indications for<br>Use | The NeoWave Pain and Recovery<br>System is indicated for the<br>temporary relief of minor muscle<br>aches and pains and for the<br>temporary increase in circulation to<br>the treated areas in people who<br>are in good health. The NeoWave<br>simulates kneading and stroking of<br>tissues by using inflatable air<br>channels. | The Perfect Touch Air<br>Massaging System is<br>indicated for the temporary<br>relief of minor muscle aches<br>and pains and for the<br>temporary increase in<br>circulation to the treated<br>areas in people who are in<br>good health. The Perfect<br>Touch simulates kneading<br>and stroking of tissues by<br>using an inflatable garment. | Same |
| OTC or Rx | OTC | OTC | Same |
| Environment<br>Of Use: | Home or clinical environment | Home environment | Same |
| Standards | IEC 60601-1: 2005<br>IEC 60601-1-2: 2014<br>IEC 60601-1-11: 2015<br>IEC 60601-1-6:2010<br>ISO 10993-10: 2010<br>ISO 10993-5: 2009 | Not available | Same, Meets<br>consensus<br>standards for ES,<br>EMC &<br>Biocompatibility |
| Principle of<br>Operation | Sequential pneumatic compression | | Same |
| Power<br>Source | 120V, 60Hz | | Same |
| Therapy Time | Has 15- or 30-minute sessions, up<br>to 30 minutes in one session, can<br>be used up to twice daily for 60<br>minutes. | Has 15-minute sessions, up<br>to 30 minutes in one session,<br>can be used up to twice daily<br>for 60 minutes. | Same |
| Number of<br>Chambers | 16 Chambers – Neck/Back<br>Cushion<br>8 Chambers – Lumbar Cushion | 12 chambers | Minor difference<br>see note in Section<br>12.3.5 |
| Table 12 | Device Comparison | | |
| Parameter | Subject Device | Predicate Device | Comparison |
| Compression<br>Applicator<br>Cushion/<br>Garments<br>Sleeve<br>Material | Compression applicator (inflatable<br>air channels inside the therapy<br>attachments): Nylon with a<br>Polyurethane laminate<br><br>Outer therapy attachment cover<br>material: 72% Polyester, 6%<br>spandex microfleece, 28% PU film | Nylon with a polyurethane<br>laminate | Similar, see note in<br>Section 12.3.6 |
| Patient<br>Contact | Non-conductive attachments | | Same |
| Sterility of the<br>Device | Non-Sterile | | Same |
| Power<br>Consumption | 30W | 26W | Similar, see note in<br>Section 12.3.7 |
| Cycle Time | 3 sec, 4 sec or 5 sec per chamber<br>Range of 24 sec to 1 min 20 sec | Range of 15 sec to 1 min 5<br>sec | Similar, see note in<br>Section 12.3.3 |
| Size<br>and<br>Photo | 8.5" x 4.25" x 7.25"<br>Image: Subject Device | 9" x 6" x 6"<br>Image: Predicate Device | Similar, see note in<br>Section 12.3.1 |
| Weight | 3 pounds | 3.2 pounds | Similar, difference<br>is immaterial |
| Housing<br>Materials and<br>Construction | Molded ABS/PC enclosure | Molded ABS enclosure | Similar, see note in<br>Section 12.3.1 |
| Reusable Life | Multi Use | | Same |
| Min & Max<br>Inflation<br>Pressure | Intermittent 113 to 149 mm Hg<br>3 Pressure Levels<br>Mild - 113-144 mm Hg<br>Medium – 127-147 mm Hg<br>Intense – 134-149 mm Hg | Intermittent 80 to 200 mm Hg<br>6 intensity settings<br>1 – 80 mm Hg<br>2 – 104 mmHg<br>3 – 128 mm Hg<br>4 - 152 mm Hg<br>5 – 176 mmHg<br>6 - 200 mmHg | Similar, Subject<br>device pressures<br>are within the range<br>of the predicate,<br>see note in Section<br>12.3.4 |
| Modes<br>(Inflation<br>sequences,<br>pre-<br>programmed) | 1 Mode: inflates and deflates chambers from bottom up (distal to<br>proximal chambers). One at a time. | | Same |
| Table 12 | Device Comparison | | |
| Parameter | Subject Device | Predicate Device | Comparison |
| Mode Visual<br>Description of<br>inflation<br>sequence | Image: Subject Device Inflation Sequence 1-4 | Image: Predicate Device Inflation Sequence 1 | Same, except<br>NeoWave has<br>more air chambers |
| | Image: Subject Device Inflation Sequence 5-8 | Image: Predicate Device Inflation Sequence 2 | |
| | Image: Subject Device Inflation Sequence 9-12 | Image: Predicate Device Inflation Sequence 3 | |
| | Image: Subject Device Inflation Sequence 13-16<br>Inflation sequence starts from the<br>bottom of the cushion and ends at<br>the neck area | Image: Predicate Device Inflation Sequence 4 | |
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| Section 5: 510(k) Summary | | | |
|---------------------------|--|--|--|
|---------------------------|--|--|--|
| Table 12 | Device Comparison | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Parameter | Subject Device | Predicate Device | Comparison |
| Neck/Back<br>Cushion<br>Picture/ Photo | Neck/Back (consisting of lower and<br>mid back and neck)<br>Image: [Neck/Back cushion]<br>Image: [Person lying on back] | Back (consisting of lower and<br>mid Back)<br>Image: [Person bending over]<br><br>Neck (consisting of upper<br>back and neck)<br>Image: [Person bending over] | Similar, see note in<br>Section 12.3.2 |
| Lumbar<br>Cushion<br>Picture | Back (consisting of lower and mid<br>back)<br>Image: [Person sitting in chair] | Back (consisting of lower<br>and mid back)<br>Image: [Person bending over] | Same |
| Table 12 | Device Comparison | | |
| Parameter | Subject Device | Predicate Device | Comparison |
| Safety<br>Features | Button on the display allows user to stop or pause therapy session<br>at any time. | | Same |
| SW/Firmware/<br>Microprocess<br>or Control | | Microprocessor | Same |
| Technology | Compressor and valve system which sequentially inflate air<br>channels of the appliance/therapy attachment | | Same |
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The NeoWave system has been compared with the Relaxor Perfect Touch Air Massaging system (K030437). The subject device has the same intended use and principles of operation, similar technological characteristics as that of the predicate devices. Although there are a few differences in specifications, a comparison analysis was completed to demonstrate that the differences would not adverselv impact the safety and effectiveness of the subject device.
### 7. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
### Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the NeoWave Pain Relief and Recovery System consisting of the Controller Unit and therapy attachments. The system complies with IEC 60601-1 Ed 3.1: 2005, IEC 60601-1-11: 2015 standards for safety and the IEC 60601-2: 2014 standard for EMC.
### Biocompatibility testing
The Biocompatibility evaluation for the NeoWave Pain Relief and Recovery System was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices. The system complies with ISO 10993-5:2009 & ISO 10993-10:2010.
### Shipping/Packaqing Testing
Testing was performed on the finished NeoWave Pain Relief and Recovery System and its finished packaging. The packaging consists of an interior box with foam where the Controller Unit is positioned and then placed inside a shipping box along with a therapy attachment as a system. The system was tested and complies with ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
### Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern since a failure or latent design flaw could indirectly result in a minor injury to the patient.
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### Mechanical Bench Testing
Performance verification testing was conducted based upon the systems Device Design Requirements. The system meets all device design criteria.
- Controller Unit Assembly Performance
- Valve Module Assembly Performance ●
- Cable/Tubing Assembly Performance
- . Neck/Back Cushion Assembly Performance
- Lumbar Cushion Assembly Performance ●
- . Life Cycle Performance
### Usability Testing
A summative study was conducted by Eva Medtec and concluded the system met all predefined usability requirements and all usability risks have been adequately mitigated.
The System's Usability Engineering File was evaluated and is compliant with IEC 60601-1-6: 2010 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral Standard.
### 8. Conclusion
Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the NeoWave Pain Relief and Recovery System is substantially equivalent to the predicate device and does not raise any new questions of safety or effectiveness.
The non-clinical data supports the safety of the device and the hardware/software verification and validation demonstrate that the NeoWave device performs as intended under the specified use conditions.
