Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on pre-programmed, timed air pressure cycles and mechanical action, with no mention of adaptive learning, data analysis for personalized therapy, or AI/ML terminology. The "microprocessor" mentioned likely controls the pre-programmed sequences, not AI/ML algorithms.

Therapeutic

Yes.
The device description explicitly states, "The NeoWave Pain Relief and Recovery System Model # T16-2020 is a reusable, nonsterile therapy device." Additionally, its intended use is for "temporary relief of minor muscle aches and pains and for the temporary increase in circulation," which are therapeutic outcomes.

Diagnostic

No

The device is described as a therapy device for pain relief and circulation, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of an air compressor, valve module(s), and therapy attachment working together as one unit, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the NeoWave Pain Relief and Recovery System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use/Indications for Use: The intended use is for the temporary relief of minor muscle aches and pains and temporary increase in circulation. This is a therapeutic purpose, not a diagnostic one.
Device Description: The device description details a pneumatic compression system that applies pressure to the body. This is a physical therapy modality, not a device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting diseases or conditions through such analysis, or providing information for diagnosis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The NeoWave system does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.

Product codes (comma separated list FDA assigned to the subject device)

IRP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Treated areas in the body (neck/back and lumbar areas are specifically mentioned for the cushions).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home or clinical environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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/Packaging 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030437

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

Page

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

2

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

4

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.

5

Summary Table of Device Comparison

| Table 12

Parameter	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 Air
Massaging System	N/A
Classification	Class II Device, IRP (21 CFR890.5650)		Same
Indications for
Use	The NeoWave Pain 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
simulates kneading and stroking of
tissues by using inflatable air
channels.	The Perfect Touch Air
Massaging 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 Perfect
Touch simulates kneading
and stroking of tissues by
using an inflatable garment.	Same
OTC or Rx	OTC	OTC	Same
Environment
Of Use:	Home or clinical environment	Home environment	Same
Standards	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	Not available	Same, Meets
consensus
standards for ES,
EMC &
Biocompatibility
Principle of
Operation	Sequential pneumatic compression		Same
Power
Source	120V, 60Hz		Same
Therapy Time	Has 15- or 30-minute sessions, up
to 30 minutes in one session, can
be used up to twice daily for 60
minutes.	Has 15-minute sessions, up
to 30 minutes in one session,
can be used up to twice daily
for 60 minutes.	Same
Number of
Chambers	16 Chambers – Neck/Back
Cushion
8 Chambers – Lumbar Cushion	12 chambers	Minor difference
see note in Section
12.3.5
Table 12	Device Comparison
Parameter	Subject Device	Predicate Device	Comparison
Compression
Applicator
Cushion/
Garments
Sleeve
Material	Compression applicator (inflatable
air channels inside the therapy
attachments): Nylon with a
Polyurethane laminate

6

7

8

Section 5: 510(k) Summary
---------------------------	--	--	--

Table 12	Device Comparison
Parameter	Subject Device	Predicate Device	Comparison
Neck/Back
Cushion
Picture/ Photo	Neck/Back (consisting of lower and
mid back and neck)
Image: [Neck/Back cushion]
Image: [Person lying on back]	Back (consisting of lower and
mid Back)
Image: [Person bending over]

9

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.

10

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.