K Number

Device Name

Normatec Go

Manufacturer

NormaTec Industries, LP

Date Cleared

2022-07-14

(36 days)

Product Code

IRP

Regulation Number

890.5650

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K220217

Reference Devices

K213745

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic controls and Bluetooth connectivity for app control, not intelligent algorithms.

Therapeutic

Yes
The stated intended use of the device is to "temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas," which aligns with the definition of a therapeutic device.

Diagnostic

The device description clearly states its purpose is to "temporarily relieve minor muscle aches" and "temporarily increase circulation," which are therapeutic functions, not diagnostic ones. There is no mention of the device identifying or detecting any medical condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a "powered, inflatable tube, calf massager" and details hardware components like a battery, control unit, buttons, and a display screen. While it has a companion app, the core medical device is a physical hardware product.

IVD (In Vitro Diagnostic)

Based on the provided information, the Normatec Go is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to temporarily relieve minor muscle aches and increase circulation. This is a physical therapy/massage function, not a diagnostic test performed on samples from the human body.
Device Description: The device is an air pressure massager that applies external pressure to the calf. It does not interact with biological samples (blood, urine, tissue, etc.) for diagnostic purposes.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
Product Code: The product code "IRP" is typically associated with physical medicine devices, not IVD devices.
Performance Studies: The performance studies focus on the device's physical and functional characteristics (air pressure, battery, software, etc.), not on the accuracy or reliability of diagnostic results.

In summary, the Normatec Go is a therapeutic device that applies external physical pressure, not a device used to diagnose conditions by analyzing samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

IRP

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Calf

Indicated Patient Age Range

Adults

Intended User / Care Setting

Clinics, hospital, athlete training, and home environments.

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 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.

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

Not Found

Predicate Device(s)

K220217

Reference Device(s)

K213745

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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.

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

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 Street
Suite A200
Watertown MA 02472	Tel - 800.355.0960
Fax - 866.279.2579
Official Contact:	Steve Henderson, Director of Quality & Regulatory Systems
Proprietary or Trade
Name:	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 Medical
Specialty:	Physical Medicine
Predicate Device:	K220217 – Normatec 3
Secondary
Predicate Device:	K213745 - Air Compression Therapy Device, model:
ST-502, Shenzhen Future Electronic Co., Ltd
Classification Name
Common/Usual	Powered inflatable tube massager
Regulation Number:	Name Massager, Powered Inflatable Tube
Product Code	21 CFR 890.5650
IRP
Regulation Medical
Specialty:	Physical Medicine

510(k) Summary Page 2 of 9

Device Description

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

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.

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 Name
510(k) Number	Normatec Go
510(k) K221666	Normatec 3
510(k) K220217	Air Compression
Therapy Device,
model: ST-502
510(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 air
pressure massager intended to
temporarily relieve minor muscle
aches and/or pains, and to
temporarily increase circulation to
the treated areas.	The Normatec 3 is an air
pressure massager intended to
temporarily relieve minor
muscle aches and/or pains, and
to temporarily increase
circulation to the treated areas.	The Air Compression Therapy
Device (model: ST-502) is
indicated for the temporary relief of
minor muscle aches and pains and
for temporary increase in
circulation to the treated areas in
people who are in good health.
The Air Compression Therapy
Device (model: ST-502) simulates
kneading and stroking of tissues
by using an inflatable garment.	The proposed and predicate
device have identical
Indications for Use. The
secondary predicate device is
included because the
maximum pressure is similar
to the proposed device.
The difference between the
proposed and secondary
predicate device is the
removal of "simulates
kneading and
stroking of tissues by using an
inflatable garment."
Anatomical Coverage	Control unit mounted to inflatable
segment with integral hoses.	Not publicly available	Control unit connected to
inflatable segments via a
hose.	Proposed device is only for
the leg
Method to secure the
device to the extremity	The device is laid open and flat.
Place device around calf, then
secure by pulling tight until Velcro
provides a snug fit against the calf.	Not publicly available	Place device around calf,
then secure by pulling
tight until Velcro holds.	The difference in method to
secure the device in place
does not raise any concerns
or safety or effectives. Neither
does it raise any new
technological characteristics.
		Page 4 of 9
	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Intended Use
Environment	Clinics, hospital, athlete
training, and home
environments	Clinics, hospital, athlete
training, and home
environments	Clinics, hospital, athlete training,
and home environments	Similar
Power Source(s)	Charging via 5 VDC compliant
power supply (100-240 VAC input)
Powered by Integrated
rechargeable battery	15 VDC via an IEC 60601-1
compliant power
supply (100-240 VAC
input)
Integrated rechargeable
battery	100-240V, 50-60Hz	Proposed device is not
operational when plugged
into the power supply.
Battery	Internal battery
3.6V, 2550mAh
Internal battery (D610-1-d1-1S1P)
3.65V, 2600mAh	Internal battery
7.2V, 3200mAh	Battery	Similar, but a smaller
battery.
Software / Firmware	Microprocessor	Microprocessor	Microprocessor	Similar
Technology	Compressor and valve system
that sequentially inflates cells.
Bluetooth communication
ability.	Compressor and valve system
that sequentially inflates cells.
Bluetooth communication
ability.	Consists of an air pump, air
pressure sensor, leg sleeves
and adapter.	Similar
Compliance with Voluntary
standards	AAMI ANSI ES60601-1, IEC
60601-1-2, IEC 60601-1-6,
IEC 60601-1-11
ANSI C63.27-2017	AAMI ANSI ES60601-1,
IEC 60601-1-2, IEC
60601-1-6,
IEC 60601-1-11
ANSI C63.27-2017	ANSI AAMI ES606011
:2005/(R)2012 and A1:2012, IEC
6060112 Edition 4.0 2014, ANSI
AAMI HA 60601111:2015	Similar
	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Performance Testing	V&V Summary
Functional Verification
Physical Features Verification
Battery Drain
Battery Charge
System Air Release
Battery Function Verification
RF Pairing Verification	V&V Summary
Functional Verification
Physical Features
Verification Battery
Drain
Battery Charge System
Air Release
Battery Function Verification	Not available	Performance Testing is
identical, though the
proposed device includes
RF 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 is
within range of cleared
secondary predicate
device.
Pressure Levels	Level 1: 40 - 70 mm Hg max
Level 2: 60 - 90 mm Hg max
Level 3: 80 - 110 mm Hg max
Level 4: 100 - 140 mm Hg max
Level 5: 130 - 170 mm Hg max
Level 6: 150 - 200 mm Hg max
Level 7: 180 - 220 mm Hg max	Level 1: 40 mm Hg max
Level 2: 50 - 60 mm Hg max
Level 3: 60 - 70 mm Hg max
Level 4: 70 - 80 mm Hg max
Level 5: 80 mm Hg max
Level 6: 80 - 90 mm Hg max
Level 7: 100 mm Hg max	Up to 240 mm Hg	Subject device has
higher max pressure
than the predicate, but
the Secondary Predicate
K213745 is up to 240
mmHg.
Treatment Time	Stays on until the user turns it off
or can be set up to turn off in a
range of 15 minutes to 60 minutes	Stays on until the user turns it off
or can be set up to turn off in a
range of 15 minutes to 60 minutes	20 minutes	Similar
Page 6 of 9
	Proposed New Device	Predicate Device	Secondary Predicate Device	Comment
Treatment Area	Calf	Leg, Arm, and Hip	Low limbs (Foot, calf, and
upper leg)	The proposed device is
intended for use only on the
calf.
The secondary predicate
device has three (3)
segments that can
operate with all (foot,
calf, and upper leg) or the
user can activate only one
segment (e.g., the calf)
Inflation/Deflation Cycle
Type	Sequential Gradient,
Peristaltic and Pulsing	Sequential Gradient,
Peristaltic and Pulsing	Sequential/Peristaltic	Similar
Contact Surface
Material	200 denier nylon with a
polyurethane
aminate/extrusion	200 denier nylon with a
polyurethane
laminate/extrusion	Polyester	Similar
Number of Inflatable
segments	3	5 or less	3	The proposed device is
physically smaller and does
not require more than 3
segments.
Weight	1.2 lbs	3.6 lbs	3.08 and 3.52 pounds	Similar
Dimensions (W x
H 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 Velcro
Controller housing
Molded ABS enclosure (94V0)	Not publicly available	Sleeve - nylon / polyester
Velcro
Controller housing
Molded ABS enclosure (94V0)	Similar
Patient contact	Non-conductive nylon containing
air bladders that when secured
around the calf by Velcro, form
zones of air tubes for compression.	Non-conductive appliances	Non-conductive attachments	Similar

510(k) Summary

Page 5 of 9

510(k) Summary

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

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).

510(k) Summary Page 9 of 9

Performance Testing

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).