The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

Device Description

The Normatec Go is a powered, inflatable tube, calf massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device is to be used by people who are in good health. The device is charged from an external compliant power supply and powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec Go is a series of buttons with one small display screen, to display the treatment time. located on the control unit mounted on the calf wrap. The user interface provides for:

. Starting and stopping the massage treatment;
. Adjusting time and intensity (pressure) of the treatment;
In addition to the user interface on the proposed device, the device also has Bluetooth capability that allows the use of the NormaTec app to control the device. The Normatec app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience

AI/ML Overview

The provided text describes a 510(k) summary for the Normatec Go device, which is an air pressure massager. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the typical format of a performance study report.

However, based on the information provided, we can infer the acceptance criteria and the types of studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table of quantitative acceptance criteria with numerical performance targets and reported values. Instead, it discusses "equivalent specifications of performance" and "met all acceptance criteria" when comparing to predicate devices. The primary performance characteristic highlighted with a numerical difference is the maximum pressure.

Acceptance Criterion (Inferred)	Reported Device Performance (Normatec Go)	Comparison to Predicate (Normatec 3)	Comparison to Secondary Predicate (ST-502)
Indications for Use	"temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas."	Identical	Similar, with minor wording difference
Prescriptive Classification	OTC	Identical	Identical
Design, Technology, and Principle of Operation	Equivalent design and features, similar technology (Compressor and valve system that sequentially inflates cells, Bluetooth communication ability, Microprocessor)	Equivalent design and features, similar technology	Similar technology (Air pump, air pressure sensor, leg sleeves, adapter)
Maximum Pressure Range	0 – 220 mm Hg	Higher (Predicate: 0 - 110 mm Hg)	Lower (Secondary Predicate: Up to 240 mm Hg)
Compliance with Standards	AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ANSI C63.27-2017	Met (Identical standards)	Met (Similar standards)
Performance Testing (Overall)	Met all acceptance criteria for: Software V&V, Functional Verification, Physical Features Verification, Battery Drain, Battery Charge, System Air Release, Battery Function Verification, RF Pairing Verification.	Identical tests, plus RF pairing testing	Not available
Patient-Contacting Materials	200 denier nylon with a polyurethane laminate/extrusion	Identical	Different (Polyester for secondary predicate)
Treatment Area	Calf only	More limited (Predicate: Leg, Arm, and Hip)	Can treat foot, calf, and upper leg (or individual zones)
Battery Performance	Passed testing with a different, smaller battery.	Different, smaller battery (Predicate: 7.2V, 3200mAh; Normatec Go: 3.6V, 2550mAh or 3.65V, 2600mAh)	Not specified for secondary predicate

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size for any specific test sets (e.g., number of devices tested, number of measurements). It only states that "Testing performed demonstrated that the proposed device meets defined requirements and performance claims."

The data provenance is not explicitly stated. The studies are described as "Performance Testing," "Verification and Validation activities," and "nonclinical tests," which are typically conducted in-house by the manufacturer (NormaTec Industries, LP) during product development and regulatory submission. No information about country of origin of data or retrospective/prospective nature is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document does not describe studies that require expert-established ground truth in the context of medical image interpretation or similar diagnostic applications. The testing described is primarily engineering and product performance verification.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. There is no mention of human-reviewed test data requiring adjudication.

5. 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

This section is not applicable. The Normatec Go is an air pressure massager, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its regulatory submission as described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is not an algorithm, but a physical massager with integrated software/firmware for control. The software V&V (Verification and Validation) was part of the performance testing, evaluating the algorithm's functionality within the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, expert consensus) is not applicable to the performance testing described for this device. The "ground truth" for the engineering performance tests would be established by objective measurements against predefined specifications (e.g., a pressure gauge to measure output pressure, a timer to measure treatment duration, electrical tests for battery performance).

8. The Sample Size for the Training Set

This section is not applicable as this device does not utilize a "training set" in the context of machine learning or AI algorithm development. The device's software is likely based on deterministic control logic, not trained models.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as #8.

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.

July 14, 2022

NormaTec Industries, LP % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K221666

Trade/Device Name: Normatec Go Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: June 6, 2022 Received: June 8, 2022

Dear Prithul Bom:

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.

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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 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 (QS) 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.

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K221666

Device Name Normatec Go

Indications for Use (Describe)

The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Page 1 of 9

NormaTec Industries, LP		Page 1 of 9
Date of Preparation:	14-Jul-22
480 Pleasant StreetSuite A200Watertown MA 02472	Tel - 800.355.0960Fax - 866.279.2579
Official Contact:	Steve Henderson, Director of Quality & Regulatory Systems
Proprietary or TradeName:	Normatec Go
Proposed Device:	Normatec Go
Common/Usual Name:	Massager, Powered Inflatable Tube
Classification Name	Powered inflatable tube massager
Regulation Number:	21 CFR 890.5650
Product Code:	IRP
Regulation MedicalSpecialty:	Physical Medicine
Predicate Device:	K220217 – Normatec 3
SecondaryPredicate Device:	K213745 - Air Compression Therapy Device, model:ST-502, Shenzhen Future Electronic Co., Ltd
Classification NameCommon/Usual	Powered inflatable tube massager
Regulation Number:	Name Massager, Powered Inflatable Tube
Product Code	21 CFR 890.5650IRP
Regulation MedicalSpecialty:	Physical Medicine

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510(k) Summary Page 2 of 9

Device Description

. Starting and stopping the massage treatment;
. Adjusting time and intensity (pressure) of the treatment;

In addition to the user interface on the proposed device, the device also has Bluetooth capability that allows the use of the NormaTec app to control the device. The Normatec app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience

Intended User ОТС

Patient Population Adults

Indications for Use

The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Intended Use Environment:

Clinics, hospital, athlete training, and home environments.

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510(k) Summary Page 3 of 9

Table 1 – Table of Device Comparisons and Differences

	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Model Name510(k) Number	Normatec Go510(k) K221666	Normatec 3510(k) K220217	Air CompressionTherapy Device,model: ST-502510(k) K213745	N/A
Manufacturer	NormaTec Industries, LP	NormaTec Industries, LP	Shenzhen Future Electronic Co.,Ltd.	N/A
Prescriptive	ОТС	ОТС	ОТС	Identical
Indications for use	The Normatec Go is an airpressure massager intended totemporarily relieve minor muscleaches and/or pains, and totemporarily increase circulation tothe treated areas.	The Normatec 3 is an airpressure massager intended totemporarily relieve minormuscle aches and/or pains, andto temporarily increasecirculation to the treated areas.	The Air Compression TherapyDevice (model: ST-502) isindicated for the temporary relief ofminor muscle aches and pains andfor temporary increase incirculation to the treated areas inpeople who are in good health.The Air Compression TherapyDevice (model: ST-502) simulateskneading and stroking of tissuesby using an inflatable garment.	The proposed and predicatedevice have identicalIndications for Use. Thesecondary predicate device isincluded because themaximum pressure is similarto the proposed device.The difference between theproposed and secondarypredicate device is theremoval of "simulateskneading andstroking of tissues by using aninflatable garment."
Anatomical Coverage	Control unit mounted to inflatablesegment with integral hoses.	Not publicly available	Control unit connected toinflatable segments via ahose.	Proposed device is only forthe leg
Method to secure thedevice to the extremity	The device is laid open and flat.Place device around calf, thensecure by pulling tight until Velcroprovides a snug fit against the calf.	Not publicly available	Place device around calf,then secure by pullingtight until Velcro holds.	The difference in method tosecure the device in placedoes not raise any concernsor safety or effectives. Neitherdoes it raise any newtechnological characteristics.
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	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Intended UseEnvironment	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athlete training,and home environments	Similar
Power Source(s)	Charging via 5 VDC compliantpower supply (100-240 VAC input)Powered by Integratedrechargeable battery	15 VDC via an IEC 60601-1compliant powersupply (100-240 VACinput)Integrated rechargeablebattery	100-240V, 50-60Hz	Proposed device is notoperational when pluggedinto the power supply.
Battery	Internal battery3.6V, 2550mAhInternal battery (D610-1-d1-1S1P)3.65V, 2600mAh	Internal battery7.2V, 3200mAh	Battery	Similar, but a smallerbattery.
Software / Firmware	Microprocessor	Microprocessor	Microprocessor	Similar
Technology	Compressor and valve systemthat sequentially inflates cells.Bluetooth communicationability.	Compressor and valve systemthat sequentially inflates cells.Bluetooth communicationability.	Consists of an air pump, airpressure sensor, leg sleevesand adapter.	Similar
Compliance with Voluntarystandards	AAMI ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-6,IEC 60601-1-11ANSI C63.27-2017	AAMI ANSI ES60601-1,IEC 60601-1-2, IEC60601-1-6,IEC 60601-1-11ANSI C63.27-2017	ANSI AAMI ES606011:2005/(R)2012 and A1:2012, IEC6060112 Edition 4.0 2014, ANSIAAMI HA 60601111:2015	Similar
	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Performance Testing	V&V SummaryFunctional VerificationPhysical Features VerificationBattery DrainBattery ChargeSystem Air ReleaseBattery Function VerificationRF Pairing Verification	V&V SummaryFunctional VerificationPhysical FeaturesVerification BatteryDrainBattery Charge SystemAir ReleaseBattery Function Verification	Not available	Performance Testing isidentical, though theproposed device includesRF pairing testing.
Clinical Testing	None	None	None	Similar
Device Pressure Range	0 – 220 mm Hg	0 - 110 mm Hg	Up to 240 mm Hg	Increased pressure iswithin range of clearedsecondary predicatedevice.
Pressure Levels	Level 1: 40 - 70 mm Hg maxLevel 2: 60 - 90 mm Hg maxLevel 3: 80 - 110 mm Hg maxLevel 4: 100 - 140 mm Hg maxLevel 5: 130 - 170 mm Hg maxLevel 6: 150 - 200 mm Hg maxLevel 7: 180 - 220 mm Hg max	Level 1: 40 mm Hg maxLevel 2: 50 - 60 mm Hg maxLevel 3: 60 - 70 mm Hg maxLevel 4: 70 - 80 mm Hg maxLevel 5: 80 mm Hg maxLevel 6: 80 - 90 mm Hg maxLevel 7: 100 mm Hg max	Up to 240 mm Hg	Subject device hashigher max pressurethan the predicate, butthe Secondary PredicateK213745 is up to 240mmHg.
Treatment Time	Stays on until the user turns it offor can be set up to turn off in arange of 15 minutes to 60 minutes	Stays on until the user turns it offor can be set up to turn off in arange of 15 minutes to 60 minutes	20 minutes	Similar
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	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Treatment Area	Calf	Leg, Arm, and Hip	Low limbs (Foot, calf, andupper leg)	The proposed device isintended for use only on thecalf.The secondary predicatedevice has three (3)segments that canoperate with all (foot,calf, and upper leg) or theuser can activate only onesegment (e.g., the calf)
Inflation/Deflation CycleType	Sequential Gradient,Peristaltic and Pulsing	Sequential Gradient,Peristaltic and Pulsing	Sequential/Peristaltic	Similar
Contact SurfaceMaterial	200 denier nylon with apolyurethaneaminate/extrusion	200 denier nylon with apolyurethanelaminate/extrusion	Polyester	Similar
Number of Inflatablesegments	3	5 or less	3	The proposed device isphysically smaller and doesnot require more than 3segments.
Weight	1.2 lbs	3.6 lbs	3.08 and 3.52 pounds	Similar
Dimensions (W xH x D)	4.94" x 1.27" x 2.76"	4.17" x 3.66" x 8.25"	L215mm x W65mm x H51mm	Similar
Materials	Wrap- nylon / polyester VelcroController housingMolded ABS enclosure (94V0)	Not publicly available	Sleeve - nylon / polyesterVelcroController housingMolded ABS enclosure (94V0)	Similar
Patient contact	Non-conductive nylon containingair bladders that when securedaround the calf by Velcro, formzones of air tubes for compression.	Non-conductive appliances	Non-conductive attachments	Similar

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510(k) Summary

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510(k) Summary

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510(k) Summary

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510(k) Summary Page 7 of 9

Determination of Substantial Equivalence

The Normatec Go is substantially equivalent to currently marketed and cleared devices (K220217) because:

Indications for Use

The Normatec Go indications for use are identical to the predicate, Normatec 3, 510(k) K220217.

Prescriptive

The Normatec Go and the predicate Normatec 3 (K220217) and secondary predicate device (K213745) are OTC devices.

Design, Technology, and Principle of Operation

The Normatec Go has equivalent design and features, and similar technology to the predicate, Normatec 3, 510(k) K220217.

Design and Technology

The proposed device Normatec Go differs in design from the predicate Normatec 3 (K220217) in the following ways:

. Normatec Go has a rechargeable battery that allows the user to operate the device without requiring the device to be connected to power like the predicate Normatec 3 (K220217). Normatec Go will not operate while the device is connected to power and charging the battery.
The control unit or Display Screen which includes the Start/Stop button. Time Adiustment button. ● and Pressure Adjustment button - is attached directly to Normatec Go.
The air hoses for the proposed device Normatec Go are contained within the device. The air tubes ● have been relocated in a service pouch to improve the aesthetic look of the device, though they are still directly connected to the control unit. For the predicate device Normatec 3 (K220217), one air hose protruded from the leg, arm, or hip appliance to connect directly to the control unit.

Method to Secure the Device

The proposed device is unfolded, then wrapped around the calf until snug. The proposed device has Velcro to ensure the device is secure and snug prior to starting treatment.

Principle of Operation

The Principle of Operation for the proposed device Normatec Go, predicate device Normatec 3 (K220217), and secondary predicate device – Air Compression Therapy Device (K213745) is identical.

Maximum Pressure

The subject device is capable of reaching up to 220 mm Hg.

The predicate device is capable of reaching up to 110 mmHg. The secondary predicate device is capable of reaching up to 240 mm Hg.

Though the maximum pressure for the proposed device Normatec Go exceeds the maximum pressure for

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510(k) Summary Page 8 of 9

the predicate device Normatec 3 (K220217), we have included a secondary predicate device with similar technology, principle of operation, and indications for use that has a maximum pressure of 20 mm Hg higher than the Normatec Go. While this pressure is higher than the predicate device Normatec 3 (K220217). this higher pressure does not raise any different safety or effectiveness concerns for the subject device Normatec Go.

Treatment Area

The proposed device Normatec Go is offered as a calf only device.

The predicate device Normatec 3 (K220217) had three models: leg, arm, and hip. While the treatment areas of the body may differ, the fundamental technology and method of treatment is identical.

The secondary predicate device Air Compression Therapy Device (K213745) can treat the foot, calf, and upper leg simultaneously or each zone independently. When operated to one specific area (i.e., calf), this is similar to the proposed device Normatec Go, which is limited to the calf only. We do not believe that treatment of only the calf muscle raises any new safety or effectiveness concerns for the proposed device Normatec Go.

Bluetooth and Smartphone Application

Both the proposed device Normatec Go and the predicate Normatec 3 have identical Bluetooth capability that allow both devices to connect to the NormaTec app. Our app is compatible with both iOS and Android platforms. The app is the identical for both the predicate Normatec 3 and the proposed Normatec Go. The user can adjust the pressure level, time and the starting and stopping of the session. The app has the same functionality as the device. The app acts like a remote control for users who do not want to use the controls located on the device.

Battery

Normatec Go passed testing with a different, smaller battery due to the size of the control unit - the size of the control unit Normatec Go is smaller than the predicate device Normatec 3 (K220217).

Performance and Specifications

The Normatec Go has equivalent specifications of performance when compared to the predicate. Normatec 3, 510(k) K220217 except for the maximum pressure. We have compared to the secondary predicate device K213745 which has similar maximum pressure limits.

Compliance with Standards

Both devices have been tested with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017 and passed the acceptance criteria.

Patient Contacting Materials

The patient-contacting materials of the Normatec Go are identical to the predicate Normatec 3 (K220217).

Intended Use Environment

Clinics, hospital, athlete training, and home environments, which are identical to the predicate.

Features

The Normatec Go has equivalent features when compared to the predicate Normatec 3 (K220217).

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510(k) Summary Page 9 of 9

Performance Testing

The Normatec Go underwent identical performance testing to the predicate Normatec 3 (K220217) with the inclusion of RF pairing testing. The testing included Software V&V, Functional Verification Physical Features Verification, Battery Drain, Battery Charge, System Air Release, Battery Function Verification and RF Pairing Verification. The subject device met all acceptance criteria.

Verification and Validation activities that established the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed. Testing performed demonstrated that the proposed device meets defined requirements and performance claims.

Animal testing There was no animal testing.

Clinical Testing There was no clinical testing.

Conclusion

The Normatec Go is substantially equivalent to the predicate Normatec 3 (K220217) in:

Patient population .
Environment of use •
Technology characteristics •
Patient Contacting Materials •
Specifications / performance, and
Compliance with international standards •

The 510(k) summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is substantially equivalent as compared to the predicate device according to 807.92(b)(3).

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).