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

Device Description

The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP.

The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

AI/ML Overview

Since this is not an AI/ML device, the traditional acceptance criteria and study design for such devices are not applicable.
This document is a 510(k) premarket notification for the NormaTec Pulse and NormaTec Pulse Pro, which are powered inflatable tube massagers. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria for substantial equivalence in this context are primarily based on comparing the new device to existing predicate devices in terms of:

Intended Use: The purpose for which the device is used.
Technological Characteristics: The fundamental scientific technology and design principles.
Performance: How the device functions and its capabilities.
Safety and Effectiveness: Ensuring that any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, outlining how the device meets these criteria through comparison with predicate devices:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Derived from Predicate Comparison)	NormaTec Pulse and Pulse Pro Reported Performance / Characteristics	Outcome Against Criteria
Indications for Use	Identical indications for use as predicate devices.	"The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas."	Met (Identical to K112890)
Contraindications	Identical contraindications as predicate devices.	Listed contraindications (e.g., inflammation, infection, DVT, etc.)	Met (Identical to predicates)
Prescription or OTC	Over-The-Counter (OTC) as predicate devices.	OTC	Met (Identical to K112890)
Power Source	Similar power source.	12 VDC via IEC 60601-1 compliant power supply (100-240 VAC input), Optional Integrated rechargeable battery.	Met (Similar; battery is an addition, not a primary functional change)
Software/Firmware/Microprocessor Control	(Not applicable for analog predicate)	Microprocessor control (compared to analog for K112890), with software providing identical core functionality and visual feedback.	Met (Difference evaluated and deemed not to impact safety/effectiveness)
Technology	Compressor and valve system for sequential inflation.	Compressor and valve system which sequentially inflates cells of appliance.	Met (Identical technology)
Compliance with Voluntary Standards	Compliance with relevant electrical safety and EMC standards.	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 (for home healthcare).	Met (Updated compliance to current versions and home use standard)
Device Pressure Range	Similar pressure range.	30-110 mmHg.	Met (Identical to K112890; broader than K122154 but justified to be safe for hip appliance due to larger body mass)
Treatment Time	Similar treatment time capabilities.	User controlled 10 minutes to 175 minutes or continuous.	Met (Extended capability from K112890, but deemed safe; adjustable vs. fixed from K122154, also deemed safe)
Inflation/Deflation Cycle Type	Sequential Gradient, Peristaltic, and Pulsing.	Sequential Gradient, Peristaltic, and Pulsing.	Met (Identical to K112890; offers more patterns than K122154, deemed safe)
Appliance Contact Surface Material	200 denier nylon with polyurethane laminate/extrusion.	200 denier nylon with a polyurethane laminate/extrusion.	Met (Identical)
Number of Inflatable Appliance Segments	5 or less.	5 or less.	Met (Identical)
Weight & Dimensions	Generally similar physical characteristics.	Weight: 3.6 lbs; Dimensions: 4"x5"x9".	Met (Similar to predicates)
Housing Materials & Constructions	Generally similar materials.	Molded ABS enclosure (94V0).	Met (Similar to predicates)
Patient Contact	Non-conductive appliances.	Non-conductive appliances.	Met (Identical)
Appliances	Types of body appliances.	Leg, Arm, Hip.	Met (Leg/Arm identical to K112890; Hip found in K122154, deemed safe)

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

The document explicitly states:

"No animal testing was performed"
"No clinical testing was performed"

Therefore, there is no "test set" in the sense of patient or animal data used to establish device performance against clinical endpoints. The evaluation for substantial equivalence relied on bench testing and comparison to predicate devices rather than clinical performance data.

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

Not applicable. As no clinical or animal testing was performed, there was no "ground truth" to be established by experts from such test sets regarding clinical outcomes. The "ground truth" for the substantial equivalence claim resides in the technical specifications, design, and performance characteristics compared to the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

Not applicable. This device is a physical therapy device (powered inflatable tube massager), not an AI/ML diagnostic or image reader assistance device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for proving substantial equivalence was based on:

Technical specifications and design documents of the NormaTec Pulse and Pulse Pro.
Technical specifications and regulatory clearances of the predicate devices (NormaTec MVP - K112890 and Figg, LLC PowerPlay model PPRT-01 - K122154).
Bench testing results demonstrating compliance with applicable electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the NormaTec Pulse and Pulse Pro met acceptance criteria for substantial equivalence was a comparison study against two predicate devices: NormaTec MVP (K112890) and Figg, LLC PowerPlay model PPRT-01 (K122154).

The acceptance criteria were met by demonstrating that the new device:

Has identical indications for use and contraindications as the primary predicate NormaTec MVP (K112890).
Utilizes identical core technology (compressor and valve system with sequential inflation).
Has similar, or improved without raising new safety/effectiveness concerns, technological characteristics (e.g., pressure range, treatment time, controls).
Complies with relevant, updated voluntary standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11).
Key differences (e.g., optional integrated battery, microprocessor control, adjustable treatment time, hip appliance, broader pressure range for hip appliance, different massage patterns) were analyzed and determined not to raise new questions of safety or effectiveness.

This evaluation was supported by bench testing to confirm the device's adherence to various controls, indicators, performance parameters, hazard mitigations, and compliance with the specified electrical and EMC standards. No animal or clinical studies were deemed necessary for this substantial equivalence determination.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 13, 2016

NormaTec Industries, LP % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K160608

Trade/Device Name: NormaTec Pulse and NormaTec Pulse Pro Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: March 28, 2016 Received: March 29, 2016

Dear Mr. Job:

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160608

Device Name

NormaTec Pulse and NormaTec Pulse Pro

Indications for Use (Describe)

The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, 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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Official Address:	NormaTec Industries, LP44 Glen AveNewton, MA 02459Tel – 617 658 5827 Fax - 617 928 3407
Official Contact:	Peter Novello – Director Manufacturing and Regulatory
Proprietary or Trade Name:	NormaTec Pulse and NormaTec Pulse Pro
Common/Usual Name:	Powered inflatable tube massager.
Classification Name/Code:	IRP - Powered inflatable tube massagerClass II
Device Name:	NormaTec Pulse and NormaTec Pulse Pro
Predicate Devices:	K112890 - NormaTec MVPK122154 - Figg, LLC PowerPlay model PPRT-01

Device Description:

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Intended User

OTC

Patient Population Adults

Indications for Use:

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

Environment of Use:

Clinics, hospital, athlete training, and home environments

Contraindications:

Do not use this product if you are experiencing inflammation, an infection, pain of . unknown origin, or bleeding (internal or external) at or near the site of application or if you have a wound at or near the site of application.
Do not use this product if you are under the care of a physician or have a condition ● requiring the use of any medical device.
Do not use this product on sensitive skin or on in the presence of poor circulation. ●
Do not use this product if you have any of the following conditions: ●
- Acute pulmonary edema O
- Acute thrombophlebitis O
- Acute congestive cardiac failure 1 o
- Acute infections O
- Deep Vein Thrombosis (DVT) O
- Episodes of Pulmonary embolism о
- Wounds lesions or tumors at or in the vicinity of application O
- Where increased venous and lymphatic return is undesirable o
- о Bone fractures or dislocations at or in the vicinity of application

These contraindications are identical to the predicate.

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Differences Between Pulse and Pulse Pro

The table below details features available on Pulse Pro that are not available on Pulse

Characteristic	PULSE	PULSE PRO
Power on: The system recalls and displays the last used settings for:	X	X
Treatment time	X	X
Treatment mode
Therapy mode		X
Rehab mode - recalls zone focus
Custom - recalls all settings
Recovery Flush
Appliance type		X
Power level	X	X
Number of zones	X	X
Rest time	X	X
Brightness settings		X
Time
Add time
Before treatment	X	X
During treatment
Decrease time
Before treatment	X	X
During treatment
Continuous mode	X	X
Counter
Count down - 1 second increments	X	X
Count up (continuous mode) – 1 second increments		X
Compliance - Trip meter – reset by User		X
Chronometer Odometer – cannot be reset by User		X
Pressure
Increase level
Before treatment	X	X
During treatment
Decrease level
Before treatment	X	X
During treatment
Treatment mode – Can only be changed before treatment begins
NormaTec Pulse	X	X
Sequential	X	X
Rest Time
View or change rest time - before treatment	X	X
# of zones
Change number of zones - before treatment	X	X
Treatment
Starting	X	X
Pause	X	X
Un-pause	X	X
End – If timer reaches 0:00⁰⁰, treatment will continue until Rest period is
reached. The user is given options to either:		X
Add time
Continue until cycle is finished
Quit
Battery charging
Displays battery level	X	X
Displays when battery is charging	X	X
Power off
No treatment in process	X	X
Treatment in process	X	X
Appliance type
Select appliance type - boot, arm, hip
Note: If hip appliance is selected, treatment mode defaults to 2-zonetreatment		X
Therapy mode
Recovery flush
Preset Pulse time / Pulse pressure valuesAppliance type applicable - Boot, arm, hip		X
Rehab
Preset Pulse time / Pulse pressure valuesLeg appliance - Foot/ankle, calf, knee, lower quad, upper quadArm appliance - hand/wrist, forearm, elbow, bicep, shoulderHip appliance - Quadriceps, hip		X
Custom Settings		X
Allows user to program NormaTec Pulse pressure and timevalues for each zone
Pressure range - 30-100 mmHg, user can select in 10mmHgincrements
Time range - 15 seconds to 4 minutes, user can select in 15second increments
Display settings adjustment
Brightness controls		X

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Predicate Device Comparison:

The Pulse and Pulse Pro were compared to the predicates NormaTec MVP - K112890 and Figg PowerPlay model PPRT-01 - K122154 in the device comparison tables below.

Model Name510(k) Number	Subject Device K160608NormaTec Pulse and PulsePro	Predicate DeviceK112890 NormaTecMVP	Comment
Manufacturer	NormaTec Industries	NormaTec Industries	Identical
Indications for use	The NormaTec Pulse and PulsePro is an air pressure massagerintended to temporarily relieveminor muscle aches and/orpains, and to temporarilyincrease circulation to thetreated areas.	The NormaTec MVP is anair pressure massagerintended to temporarilyrelieve minor muscleaches and/or pains, and totemporarily increasecirculation to the treatedareas.	Identical
Contraindications	Specified below	Specified below	Identical
Prescriptive orOTC	OTC	OTC	Identical
Power Source(s)	12 VDC via an IEC 60601-1compliant power supply (100-240 VAC input)Optional Integratedrechargeable battery	12 VDC via an IEC60601-1 compliant powersupply (100 - 240 VACinput)	Pulse and Pulse Prohave an optionalintegral battery notrequired forfunction.
Software/Firmware/MicroprocessorControl	Microprocessor	Analog	Software providesidentical controlfunctionality,additionallyprovides visualfeedback
Technology	Compressor and valve systemwhich sequentially inflates cellsof appliance	Compressor and valvesystem which sequentiallyinflates cells of appliance	Identical technology
Compliance withVoluntarystandards	ES 60601-1, IEC 60601-1-2,IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2	Pulse / Pulse Procomplies withcurrently recognizedversion of 60601-1and home usestandard
DevicePressure range	30-110 mmHg	30 - 110 mmHg	Identical
Treatment Time	Stays on until the user turns itoff or can be set up to turn offin a range of 10 mins tocontinuous	Stays on until the userturns it off	Added ability totime treatment
Inflation/deflationcycle type	Sequential Gradient, Peristalticand	Sequential Gradient,Peristaltic and Pulsing	Identical
Appliance contactsurface material	200 denier nylon with apolyurethanelaminate/extrusion	200 denier nylon with apolyurethanelaminate/extrusion	Identical
Number ofInflatableappliance segments	5 or less	5 or less	Identical
Weight	3.6 pounds (incl. battery)	8 pounds	Similar
Dimensions (W x Hx D)	4" x 5" x 9"	11" x 6.5" x 7"	Similar
Housing MaterialsandConstructions	Molded ABS enclosure (94V0)	Thermoplastic	Similar
Patient contact	Non-conductive appliances	Non-conductiveappliances	Identical
Appliances	Leg, Arm, Hip	Leg, Arm	Leg and Armappliancesare identical to510(k)K112890.A hip appliance isavailable as part ofpredicate K122154
Parameter	Subject Device K160608NormaTec Pulse and Pulse Pro	Predicate K122154Power Play	Comment
Treatment Time	User controlled 10 minutes to175 minutes or continuous -totaltime over 4 segments	20 minutes max per port(segments)	The Pulse and PulsePro allow the user toadjust the treatmenttime while thepredicate device(K112154) time isfixed at 20 minutes.There is no impact tosafety oreffectiveness withthis adjustable optionand ability to select alonger treatment timewith the hipappliance.
Pressure Range	30-110 mmHG	30-70 mmHG	The Pulse and PulsePro have a broaderpressure range thanthe predicate device(K112154) withmaximum pressure of

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appliances.

510(k) Summary
			110mmHG. Thispressure is the samemaximum used onthe Pulse and PulsePro Arm and Legappliances (andpredicate NormaTecMVP 510(k)K112890). As the hiparea is a larger bodymass than the armand leg appendages,this higher pressurepresents nocompromises tosafety oreffectiveness to theuser wearing the hipappliance.
Inflation Cycle /Pulsing	Preinflate ,then either sequentialor peristaltic Pulsing as selectedby user-with adjustable rest time	Preinflate, rest, deflate thenrepeat the sequencing	The Pulse and PulsePro have 2 differentmassage patterns thatcan be selected by theuser as well as havingthe option to adjustthe rest time. Thepredicate device(K112154) has apredetermined cycleand rest-time. Thereis no impact of safetyor effectiveness withthe differences in themassage patternsbetween theNormaTec and thepredicate's hip

510(k) Summary

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Performance Testing

Bench:

The device has been tested to ensure that it all requirements have been met, this includes:

Testing of all controls ●
Testing of all indicators
Testing of battery state indicators
Testing of performance
. Testing of hazard mitigations

The device has also been tested to the requirements of the following standards:

AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment - part 1: ● general requirements for basic safety and essential performance

IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility - Requirements ● and Tests

IEC 60601-1-11: 2010, Collateral standard: requirements for medical electrical ● equipment and medical electrical systems used in the home healthcare environment

Animal:

No animal testing was performed

Clinical:

No clinical testing was performed

Conclusion

The NormaTec Pulse and Pulse Pro are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.

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).