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.

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 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.

AI/ML Overview

This document outlines the acceptance criteria and study information for the NeoWave Pain Relief and Recovery System based on the provided text.

Acceptance Criteria and Reported Device Performance

No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) were provided in the document. The substantial equivalence determination is primarily based on performance in general safety, electrical safety, EMC, biocompatibility, packaging, software verification, mechanical bench testing, and usability in comparison to a predicate device.

The table below summarizes the technical comparison provided in the document.

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)	Comparison
General
Manufacturer	SALTON, INC.	EVA MEDTEC, INC.	N/A (Different companies)
510(K) Number	K030437	K202693	N/A (Different K-numbers)
Model Name	Relaxor Perfect Touch Air Massaging System	NeoWave System T16-2020	N/A (Different names)
Classification	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Same
Indications for Use	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. Simulates kneading and stroking of tissues by using an inflatable garment.	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. Simulates kneading and stroking of tissues by using inflatable air channels.	Same
OTC or Rx	OTC	OTC	Same
Environment Of Use	Home environment	Home or clinical environment	Same (Includes home, extends to clinical)
Principle of Operation	Sequential pneumatic compression	Sequential pneumatic compression	Same
Power Source	120V, 60Hz	120V, 60Hz (External power supply of 12V DC mentioned for controller unit, but ultimate source usually 120V in US)	Same (Assuming the 12V DC is from an adapter connected to 120V)
Sterility of the Device	Not specified but implied non-sterile for this type of device.	Non-Sterile	Same (Explicitly stated for subject device)
Reusable Life	Not specified but implied Multi Use.	Multi Use	Same (Explicitly stated for subject device)
SW/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Same
Technology	Compressor and valve system which sequentially inflate air channels of the appliance/therapy attachment	Compressor and valve system which sequentially inflate air channels of the appliance/therapy attachment	Same
Physical/Operational Characteristics
Therapy Time	Has 15-minute sessions, up to 30 minutes in one session, can be used up to twice daily for 60 minutes.	Has 15- or 30-minute sessions, up to 30 minutes in one session, can be used up to twice daily for 60 minutes.	Same
Number of Chambers	12 chambers	16 Chambers – Neck/Back Cushion; 8 Chambers – Lumbar Cushion	Minor difference (Subject device has more chambers in one configuration)
Compression Applicator/Cushion/Garment Material	Nylon with a polyurethane laminate	Compression applicator (inflatable air channels inside the therapy attachments): Nylon with a Polyurethane laminate. Outer therapy attachment cover material: 72% Polyester, 6% spandex microfleece, 28% PU film.	Similar (Similar core material, subject device has an additional outer cover)
Power Consumption	26W	30W	Similar (Slightly higher power consumption for subject device)
Cycle Time (per chamber)	Range of 15 sec to 1 min 5 sec	3 sec, 4 sec or 5 sec per chamber; Range of 24 sec to 1 min 20 sec (for an entire cycle, not per chamber)	Similar (Cycle time range slightly different, but overall similar function)
Size	9" x 6" x 6"	8.5" x 4.25" x 7.25"	Similar (Slightly different dimensions)
Weight	3.2 pounds	3 pounds	Similar (Marginal difference)
Housing Materials and Construction	Molded ABS enclosure	Molded ABS/PC enclosure	Similar (ABS/PC is a common variant of ABS)
Min & Max Inflation Pressure	Intermittent 80 to 200 mm Hg, 6 intensity settings (1 – 80 mm Hg, 2 – 104 mmHg, 3 – 128 mm Hg, 4 - 152 mm Hg, 5 – 176 mmHg, 6 - 200 mmHg)	Intermittent 113 to 149 mm Hg, 3 Pressure Levels (Mild - 113-144 mm Hg, Medium – 127-147 mm Hg, Intense – 134-149 mm Hg)	Similar (Subject device pressures are within the range of the predicate)
Modes (Inflation sequences, pre-programmed)	Not explicitly detailed, but implied sequential inflation.	1 Mode: inflates and deflates chambers from bottom up (distal to proximal chambers). One at a time.	Similar (Both use sequential inflation)
Safety Features	Not explicitly detailed, but expected to have basic safety features common to such devices.	Button on the display allows user to stop or pause therapy session at any time.	Same (Fundamental safety feature)
Patient Contact	Not specified, but implied non-conductive.	Non-conductive attachments	Same (Explicitly stated for subject device)
Standards	Not available (for predicate)	IEC 60601-1: 2005, IEC 60601-1-2: 2014, IEC 60601-1-11: 2015, IEC 60601-1-6:2010, ISO 10993-10: 2010, ISO 10993-5: 2009	Same, Meets consensus standards for ES, EMC & Biocompatibility (for subject device)

Study Information

This document does not describe a clinical study comparing diagnostic accuracy or clinical outcomes. Instead, it relies on a series of non-clinical performance tests and comparisons to a predicate device to establish substantial equivalence.

Sample size used for the test set and the data provenance: Not applicable. The studies conducted are non-clinical (electrical safety, EMC, biocompatibility, software verification, mechanical bench testing, usability). These tests are typically performed on samples of the manufactured device and its components, not on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance is established by compliance with engineering standards and design requirements, not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no diagnostic test set requiring expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical therapy device (massager), not an AI-assisted diagnostic or assistive device for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical studies conducted:
- Electrical safety and EMC: Compliance with international standards (IEC 60601-1, IEC 60601-1-2) defines the "ground truth."
- Biocompatibility testing: Compliance with international standards (ISO 10993-1, ISO 10993-5, ISO 10993-10) defines the "ground truth."
- Shipping/Packaging Testing: Compliance with ASTM D4169-16 defines the "ground truth."
- Software Verification and Validation Testing: Compliance with FDA guidance for software in medical devices and internal design requirements defines the "ground truth."
- Mechanical Bench Testing: Meeting the system's Device Design Requirements defines the "ground truth."
- Usability Testing: Meeting predefined usability requirements and adequate mitigation of usability risks, in compliance with IEC 60601-1-6, defines the "ground truth."
The sample size for the training set: Not applicable. As a medical device that performs mechanical action, it doesn't involve machine learning or AI models that require training data.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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:

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 12Parameter	Device Comparison		Comparison
Manufacturer	Subject Device	Predicate Device
	EVA MEDTEC, INC.	SALTON, INC.	N/A
510(K)Number	K202693	K030437	N/A
Model Name	NeoWave System T16-2020	Relaxor Perfect Touch AirMassaging System	N/A
Classification	Class II Device, IRP (21 CFR890.5650)		Same
Indications forUse	The NeoWave Pain and RecoverySystem is indicated for thetemporary relief of minor muscleaches and pains and for thetemporary increase in circulation tothe treated areas in people whoare in good health. The NeoWavesimulates kneading and stroking oftissues by using inflatable airchannels.	The Perfect Touch AirMassaging System isindicated for the temporaryrelief of minor muscle achesand pains and for thetemporary increase incirculation to the treatedareas in people who are ingood health. The PerfectTouch simulates kneadingand stroking of tissues byusing an inflatable garment.	Same
OTC or Rx	OTC	OTC	Same
EnvironmentOf Use:	Home or clinical environment	Home environment	Same
Standards	IEC 60601-1: 2005IEC 60601-1-2: 2014IEC 60601-1-11: 2015IEC 60601-1-6:2010ISO 10993-10: 2010ISO 10993-5: 2009	Not available	Same, Meetsconsensusstandards for ES,EMC &Biocompatibility
Principle ofOperation	Sequential pneumatic compression		Same
PowerSource	120V, 60Hz		Same
Therapy Time	Has 15- or 30-minute sessions, upto 30 minutes in one session, canbe used up to twice daily for 60minutes.	Has 15-minute sessions, upto 30 minutes in one session,can be used up to twice dailyfor 60 minutes.	Same
Number ofChambers	16 Chambers – Neck/BackCushion8 Chambers – Lumbar Cushion	12 chambers	Minor differencesee note in Section12.3.5
Table 12	Device Comparison
Parameter	Subject Device	Predicate Device	Comparison
CompressionApplicatorCushion/GarmentsSleeveMaterial	Compression applicator (inflatableair channels inside the therapyattachments): Nylon with aPolyurethane laminateOuter therapy attachment covermaterial: 72% Polyester, 6%spandex microfleece, 28% PU film	Nylon with a polyurethanelaminate	Similar, see note inSection 12.3.6
PatientContact	Non-conductive attachments		Same
Sterility of theDevice	Non-Sterile		Same
PowerConsumption	30W	26W	Similar, see note inSection 12.3.7
Cycle Time	3 sec, 4 sec or 5 sec per chamberRange of 24 sec to 1 min 20 sec	Range of 15 sec to 1 min 5sec	Similar, see note inSection 12.3.3
SizeandPhoto	8.5" x 4.25" x 7.25"Image: Subject Device	9" x 6" x 6"Image: Predicate Device	Similar, see note inSection 12.3.1
Weight	3 pounds	3.2 pounds	Similar, differenceis immaterial
HousingMaterials andConstruction	Molded ABS/PC enclosure	Molded ABS enclosure	Similar, see note inSection 12.3.1
Reusable Life	Multi Use		Same
Min & MaxInflationPressure	Intermittent 113 to 149 mm Hg3 Pressure LevelsMild - 113-144 mm HgMedium – 127-147 mm HgIntense – 134-149 mm Hg	Intermittent 80 to 200 mm Hg6 intensity settings1 – 80 mm Hg2 – 104 mmHg3 – 128 mm Hg4 - 152 mm Hg5 – 176 mmHg6 - 200 mmHg	Similar, Subjectdevice pressuresare within the rangeof the predicate,see note in Section12.3.4
Modes(Inflationsequences,pre-programmed)	1 Mode: inflates and deflates chambers from bottom up (distal toproximal chambers). One at a time.		Same
Table 12	Device Comparison
Parameter	Subject Device	Predicate Device	Comparison
Mode VisualDescription ofinflationsequence	Image: Subject Device Inflation Sequence 1-4	Image: Predicate Device Inflation Sequence 1	Same, exceptNeoWave hasmore 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 13-16Inflation sequence starts from thebottom of the cushion and ends atthe 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/BackCushionPicture/ Photo	Neck/Back (consisting of lower andmid back and neck)Image: [Neck/Back cushion]Image: [Person lying on back]	Back (consisting of lower andmid Back)Image: [Person bending over]Neck (consisting of upperback and neck)Image: [Person bending over]	Similar, see note inSection 12.3.2
LumbarCushionPicture	Back (consisting of lower and midback)Image: [Person sitting in chair]	Back (consisting of lowerand mid back)Image: [Person bending over]	Same
Table 12	Device Comparison
Parameter	Subject Device	Predicate Device	Comparison
SafetyFeatures	Button on the display allows user to stop or pause therapy sessionat any time.		Same
SW/Firmware/Microprocessor Control		Microprocessor	Same
Technology	Compressor and valve system which sequentially inflate airchannels 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.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
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.(b)
Classification. Class II (performance standards).