NormaTec Pulse and NormaTec Pulse Pro

K160608 · NormaTec Industries, LP · IRP · Apr 13, 2016 · Physical Medicine

Device Facts

• Record ID: K160608
• Device Name: NormaTec Pulse and NormaTec Pulse Pro
• Applicant: NormaTec Industries, LP
• Product Code: IRP · Physical Medicine
• Decision Date: Apr 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

NormaTec Pulse and Pulse Pro are powered inflatable tube massagers for OTC use in clinics, hospitals, or home environments. Devices consist of an air compressor unit, control system, inflatable appliances (arms, legs, hips), and air tubing. System simulates manual kneading and stroking via sequential inflation of appliance cells. User operates device via TFT screen (Pulse Pro) or LCD/keypad (Pulse) to select treatment mode, pressure (30-110 mmHg), and time. Powered by external AC-DC adapter or internal lithium-ion battery. Output is mechanical pressure applied to limbs/hips to increase circulation and relieve muscle aches. Healthcare providers or patients use output to manage recovery; device provides visual feedback on treatment status. Benefits include temporary pain relief and improved circulation.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including verification of controls, indicators, battery state, performance, and hazard mitigations, alongside compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-1-11 standards.

Technological Characteristics

Powered inflatable tube massager; compressor and valve system; 200 denier nylon with polyurethane laminate/extrusion appliances; molded ABS enclosure (94V0); 12 VDC power via IEC 60601-1 compliant supply or internal Li-ion battery; microprocessor-controlled; 30-110 mmHg pressure range; 5 or fewer inflatable segments; connectivity via proprietary connectors; home healthcare environment compliant.

Indications for Use

Indicated for adults in good health for temporary relief of minor muscle aches/pains and temporary increase in circulation to treated areas. Contraindicated for patients with inflammation, infection, pain of unknown origin, bleeding, wounds, sensitive skin, poor circulation, acute pulmonary edema, acute thrombophlebitis, acute congestive cardiac failure, acute infections, DVT, pulmonary embolism, lesions/tumors, or bone fractures/dislocations at or near application site.

Regulatory Classification

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.

Predicate Devices

• NormaTec MVP (K112890)
• Figg, LLC PowerPlay model PPRT-01 (K122154)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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, LP<br>44 Glen Ave<br>Newton, MA 02459<br>Tel – 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 massager<br>Class II |
| Device Name: | NormaTec Pulse and NormaTec Pulse Pro |
| Predicate Devices: | K112890 - NormaTec MVP<br>K122154 - Figg, LLC PowerPlay model PPRT-01 |

#### 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.

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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 |
| <b>Time</b> | | |
| 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 |
| <b>Pressure</b> | | |
| 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 |
| <b>Rest Time</b> | | |
| View or change rest time - before treatment | X | X |
| <b># of zones</b> | | |
| Change number of zones - before treatment | X | X |
| <b>Treatment</b> | | |
| 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-zone<br>treatment | | X |
| Therapy mode | | |
| Recovery flush | | |
| Preset Pulse time / Pulse pressure values<br>Appliance type applicable - Boot, arm, hip | | X |
| Rehab | | |
| Preset Pulse time / Pulse pressure values<br>Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad<br>Arm appliance - hand/wrist, forearm, elbow, bicep, shoulder<br>Hip appliance - Quadriceps, hip | | X |
| Custom Settings | | X |
| Allows user to program NormaTec Pulse pressure and time<br>values for each zone | | |
| Pressure range - 30-100 mmHg, user can select in 10mmHg<br>increments | | |
| Time range - 15 seconds to 4 minutes, user can select in 15<br>second 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 Name<br>510(k) Number | Subject Device K160608<br>NormaTec Pulse and Pulse<br>Pro | Predicate Device<br>K112890 NormaTec<br>MVP | Comment |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NormaTec Industries | NormaTec Industries | Identical |
| Indications for use | The NormaTec Pulse and Pulse<br>Pro is an air pressure massager<br>intended to temporarily relieve<br>minor muscle aches and/or<br>pains, and to temporarily<br>increase circulation to the<br>treated areas. | The NormaTec MVP is an<br>air pressure massager<br>intended to temporarily<br>relieve minor muscle<br>aches and/or pains, and to<br>temporarily increase<br>circulation to the treated<br>areas. | Identical |
| Contraindications | Specified below | Specified below | Identical |
| Prescriptive or<br>OTC | OTC | OTC | Identical |
| Power Source(s) | 12 VDC via an IEC 60601-1<br>compliant power supply (100-<br>240 VAC input)<br>Optional Integrated<br>rechargeable battery | 12 VDC via an IEC<br>60601-1 compliant power<br>supply (100 - 240 VAC<br>input) | Pulse and Pulse Pro<br>have an optional<br>integral battery not<br>required for<br>function. |
| Software/Firmwar<br>e/Microprocessor<br>Control | Microprocessor | Analog | Software provides<br>identical control<br>functionality,<br>additionally<br>provides visual<br>feedback |
| Technology | Compressor and valve system<br>which sequentially inflates cells<br>of appliance | Compressor and valve<br>system which sequentially<br>inflates cells of appliance | Identical technology |
| Compliance with<br>Voluntary<br>standards | ES 60601-1, IEC 60601-1-2,<br>IEC 60601-1-11 | IEC 60601-1, IEC 60601-<br>1-2 | Pulse / Pulse Pro<br>complies with<br>currently recognized<br>version of 60601-1<br>and home use<br>standard |
| Device<br>Pressure range | 30-110 mmHg | 30 - 110 mmHg | Identical |
| Treatment Time | Stays on until the user turns it<br>off or can be set up to turn off<br>in a range of 10 mins to<br>continuous | Stays on until the user<br>turns it off | Added ability to<br>time treatment |
| Inflation/deflation<br>cycle type | Sequential Gradient, Peristaltic<br>and | Sequential Gradient,<br>Peristaltic and Pulsing | Identical |
| Appliance contact<br>surface material | 200 denier nylon with a<br>polyurethane<br>laminate/extrusion | 200 denier nylon with a<br>polyurethane<br>laminate/extrusion | Identical |
| Number of<br>Inflatable<br>appliance segments | 5 or less | 5 or less | Identical |
| Weight | 3.6 pounds (incl. battery) | 8 pounds | Similar |
| Dimensions (W x H<br>x D) | 4" x 5" x 9" | 11" x 6.5" x 7" | Similar |
| Housing Materials<br>and<br>Constructions | Molded ABS enclosure (94V0) | Thermoplastic | Similar |
| Patient contact | Non-conductive appliances | Non-conductive<br>appliances | Identical |
| Appliances | Leg, Arm, Hip | Leg, Arm | Leg and Arm<br>appliances<br>are identical to<br>510(k)<br>K112890.<br>A hip appliance is<br>available as part of<br>predicate K122154 |
| Parameter | Subject Device K160608<br>NormaTec Pulse and Pulse Pro | Predicate K122154<br>Power Play | Comment |
| Treatment Time | User controlled 10 minutes to<br>175 minutes or continuous -total<br>time over 4 segments | 20 minutes max per port<br>(segments) | The Pulse and Pulse<br>Pro allow the user to<br>adjust the treatment<br>time while the<br>predicate device<br>(K112154) time is<br>fixed at 20 minutes.<br>There is no impact to<br>safety or<br>effectiveness with<br>this adjustable option<br>and ability to select a<br>longer treatment time<br>with the hip<br>appliance. |
| Pressure Range | 30-110 mmHG | 30-70 mmHG | The Pulse and Pulse<br>Pro have a broader<br>pressure range than<br>the predicate device<br>(K112154) with<br>maximum pressure of |

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appliances.

| 510(k) Summary | | | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 110mmHG. This<br>pressure is the same<br>maximum used on<br>the Pulse and Pulse<br>Pro Arm and Leg<br>appliances (and<br>predicate NormaTec<br>MVP 510(k)<br>K112890). As the hip<br>area is a larger body<br>mass than the arm<br>and leg appendages,<br>this higher pressure<br>presents no<br>compromises to<br>safety or<br>effectiveness to the<br>user wearing the hip<br>appliance. |
| Inflation Cycle /<br>Pulsing | Preinflate ,then either sequential<br>or peristaltic Pulsing as selected<br>by user<br>-with adjustable rest time | Preinflate, rest, deflate then<br>repeat the sequencing | The Pulse and Pulse<br>Pro have 2 different<br>massage patterns that<br>can be selected by the<br>user as well as having<br>the option to adjust<br>the rest time. The<br>predicate device<br>(K112154) has a<br>predetermined cycle<br>and rest-time. There<br>is no impact of safety<br>or effectiveness with<br>the differences in the<br>massage patterns<br>between the<br>NormaTec and the<br>predicate'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.