Normatec Elite

K240122 · NormaTec Industries, LP · IRP · Mar 21, 2024 · Physical Medicine

Device Facts

• Record ID: K240122
• Device Name: Normatec Elite
• Applicant: NormaTec Industries, LP
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Normatec Elite 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 Elite is a powered inflatable tube massager for adult use in clinics, hospitals, athlete training, or home environments. Device consists of inflatable leg boots with an integrated control unit and hoses; powered by internal rechargeable lithium-ion battery or external power supply. User interface on control unit or via Bluetooth-connected mobile app allows adjustment of treatment time, pressure levels (0-110 mm Hg), and zone boost. Device uses compressor and valve system to perform sequential gradient, peristaltic, and pulsing massage to simulate manual kneading. Output is mechanical pressure applied to limbs. Healthcare providers or patients use device to manage muscle aches and circulation; output provides temporary relief and recovery benefits.

Clinical Evidence

Bench testing only. Testing included verification of controls, indicators, battery state, performance, and hazard mitigations. Biocompatibility was established by using identical materials to the predicate device.

Technological Characteristics

Powered inflatable tube massager; 200 denier nylon with polyurethane laminate/extrusion; molded ABS housing (94V0). Energy source: 12 VDC power supply (100-240 VAC) and internal rechargeable lithium-ion battery (IEC 62133-2 compliant). Connectivity: Bluetooth for mobile app control. Sequential gradient, peristaltic, and pulsing inflation. Microprocessor-controlled.

Indications for Use

Indicated for adults to temporarily relieve minor muscle aches and/or pains and increase circulation to treated areas.

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 3 (K220217)

Reference Devices

• Normatec Go (K221666)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

March 21, 2024

NormaTec Industries, LP % Matt Dryden Director ProMedic. LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K240122

Trade/Device Name: Normatec Elite Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: March 18, 2024 Received: March 18, 2024

Dear Matt Dryden:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Expiration Date: 07/31/2026 See PRA Statement below.

Form Approved: OMB No. 0910-0120

Submission Number (if known)

K240122

Device Name

Normatec Elite

Indications for Use (Describe)

The Normatec Elite 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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# NormaTec Industries, LP

| Date of Preparation: | January 15, 2024 |
|---------------------------------------------------------|-----------------------------------------------------------|
| 480 Pleasant Street<br>Suite A200<br>Watertown MA 02472 | Tel - 800.355.0960<br>Fax - 866.279.2579 |
| Official Contact: | Steve Henderson, Director of Quality & Regulatory Systems |
| Proprietary or Trade<br>Name: | Normatec Elite |
| Proposed Device: | Normatec Elite |
| Common/Usual Name: | Massager, Powered Inflatable Tube |
| Classification Name | Powered inflatable tube massager |
| Regulation Number: | 21 CFR 890.5650 |
| Product Code: | IRP |
| Regulation Medical<br>Speciality: | Physical Medicine |
| Predicate Device: | K220217 – Normatec 3 |
| Reference Device: | K221666 – Normatec Go |
| Classification Name | Powered inflatable tube massager |
| Common/Usual Name | Massager, Powered Inflatable Tube |
| Regulation Number: | 21 CFR 890.5650 |
| Product Code | IRP |
| Regulation Medical<br>Speciality: | Physical Medicine |

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# Device Description

The Normatec Elite is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for:

- Starting and stopping the massage treatment; .
- . Adjusting time and intensity (pressure) of the treatment;
- Selection of the zone to boost the pressure .

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

Intended User

OTC

### Patient Population

Adults

### Indications for Use

The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches 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 Device<br>Normatec Elite | Predicate Device<br>Normatec 3 – K220217 | Reference Device<br>Normatec Go – K221666 | Comment |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NormaTec Industries, LP | NormaTec Industries, LP | NormaTec Industries, LP | |
| Prescriptive | OTC | OTC | OTC | Identical |
| Indications for use | The Normatec Elite is an air<br>pressure massager intended to<br>temporarily relieve minor muscle<br>aches and/or pains, and to<br>temporarily increase circulation to<br>the treated areas. | The Normatec 3 is an air<br>pressure massager intended to<br>temporarily relieve minor<br>muscle aches and/or pains, and<br>to temporarily increase<br>circulation to the treated areas. | The Normatec Go is an air<br>pressure massager intended to<br>temporarily relieve minor<br>muscle aches and/or pains, and<br>to temporarily increase<br>circulation to the treated areas. | Identical |
| Anatomical<br>Coverage | Control unit mounted to inflatable<br>segment with integral hoses.<br>Image: Normatec Elite device | Control unit connected to<br>inflatable segments via a hose.<br>Image: Normatec 3 device | Control unit mounted to<br>inflatable segment with integral<br>hoses.<br>Image: Normatec Go device | The proposed device has a smaller<br>control unit version of predicate<br>device, which eliminates the hose<br>and mounting the control unit<br>directly on the inflatable patient<br>part.<br>The reference device is included<br>only to demonstrate that FDA has<br>previously cleared a NormaTec<br>device with a similar control unit<br>mounted directly to the device<br>itself. |
| Intended Use<br>Environment | Clinics, hospital, athlete training,<br>and home environments | Clinics, hospital, athlete training,<br>and home environments | Clinics, hospital, athlete training,<br>and home environments | Identical |
| | Proposed Device<br>Normatec Elite | Predicate Device<br>Normatec 3 - K220217 | Reference Device<br>Normatec Go – K221666 | Comment |
| Power Source(s) | 12 VDC via an IEC 60601-1<br>compliant power supply (100-<br>240 VAC input)<br>Integrated rechargeable battery | 15 VDC via an IEC 60601-1<br>compliant power supply (100-<br>240 VAC input)<br>Integrated rechargeable battery | Charging via 5 VDC<br>compliant power supply (100-<br>240 VAC input)<br>Powered by integrated<br>rechargeable battery | Similar<br>Normatec Elite and Normatec 3<br>are operational when plugged into<br>the power supply, though Elite has<br>a different power supply. |
| Software /<br>Firmware<br>Micro-processor<br>Control | Microprocessor | Microprocessor | Microprocessor | Identical |
| Technology | Compressor and valve system that<br>sequentially inflates cells.<br>Bluetooth communication ability. | Compressor and valve system<br>that sequentially inflates cells.<br>Bluetooth communication<br>ability. | Compressor and valve system<br>that sequentially inflates cells.<br>Bluetooth communication<br>ability. | Identical |
| Device Pressure<br>range | 0 - 110 mm Hg | 0 - 110 mm Hg | 0 – 220 mm Hg | Identical |
| Pressure Levels | Level 1: 40 mm Hg<br>Level 2: 50 - 60 mm Hg<br>Level 3: 60 - 70 mm Hg<br>Level 4: 70 - 80 mm Hg<br>Level 5: 80 mm Hg<br>Level 6: 80 - 90 mm Hg<br>Level 7: 100 mm Hg | Level 1: 40 mm Hg<br>Level 2: 50 - 60 mm Hg<br>Level 3: 60 - 70 mm Hg<br>Level 4: 70 - 80 mm Hg<br>Level 5: 80 mm Hg<br>Level 6: 80 - 90 mm Hg<br>Level 7: 100 mm Hg | Level 1: 40 - 70 mm Hg<br>Level 2: 60 - 90 mm Hg<br>Level 3: 80 - 110 mm Hg<br>Level 4: 100 - 140 mm Hg<br>Level 5: 130 - 170 mm Hg<br>Level 6: 150 - 200 mm Hg<br>Level 7: 180 - 220 mm Hg | Identical |
| Treatment Time | Stays on until the user turns it off<br>or can be set up to turn off in a<br>range of 15 minutes to 60 minutes | Stays on until the user turns it<br>off or can be set up to turn off in<br>a range of 15 minutes to 60<br>minutes | Stays on until the user turns it<br>off or can be set up to turn off in<br>a range of 15 minutes to 60<br>minutes | Identical |
| | Proposed Device<br>Normatec Elite | Predicate Device<br>Normatec 3 – K220217 | Reference Device<br>Normatec Go – K221666 | Comment |
| Inflation/Deflation<br>Cycle Type | Sequential Gradient, Peristaltic<br>and Pulsing | Sequential Gradient, Peristaltic<br>and Pulsing | Sequential Gradient, Peristaltic<br>and Pulsing | Identical |
| Contact Surface<br>Material | 200 denier nylon with a<br>polyurethane laminate/extrusion | 200 denier nylon with a<br>polyurethane laminate/extrusion | 200 denier nylon with a<br>polyurethane laminate/extrusion | Identical |
| Number of<br>Inflatable segments | 5 segments for leg attachment | 5 segments for leg attachment<br>2 segments for hip attachment<br>5 segments for arm attachment | 3 | Identical<br>Normatec Elite does not contain a<br>hip or arm attachments. |
| Weight | 3.0 lbs | 3.6 lbs | 1.2 lbs | Similar |
| Control Unit<br>Dimensions<br>(W x H x D) | 3.5" x 1.75" x 7.0" | 4.17" x 3.66" x 8.25" | 4.94" x 1.27" x 2.76" | Similar |
| Housing Materials<br>and Construction | Molded ABS enclosure (94V0) | Molded ABS enclosure (94V0) | Molded ABS enclosure (94V0) | Identical |
| Patient contact | Non-conductive wrap<br>Surface Device<br>Intact Skin<br>Limited Duration (<24 hours) | Non-conductive wrap<br>Surface Device<br>Intact Skin<br>Limited Duration (<24 hours) | Non-conductive wrap<br>Surface Device<br>Intact Skin<br>Limited Duration (<24 hours) | Identical |
| | | | | |

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# Normatec Elite

#### 510(k) Summary Page 4 of 9

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# Normatec Elite

### 510(k) Summary Page 5 of 9

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# 510(k) Summary
Page 6 of 9

# Differences Between Models

An "X" indicates the feature is present in the device.

| Characteristic | Normatec Elite | Normatec 3 |
|------------------------------------------------|----------------|------------|
| Power On - The system has settings for: | | |
| Adjustable Treatment time (15 min to 60 min) | X | X |
| Inflatable Leg Boot | X | X |
| 7 Pressure Levels | X | X |
| 5 zone Inflatable leg boot | X | X |
| Adjustable Rest time | N/A | X |
| Time | | |
| User can Add time | | |
| Before treatment | X | X |
| During treatment | | |
| User can Decrease time | | |
| Before treatment | X | X |
| During treatment | | |
| Provides a Counter | X | X |
| Count down - 1 second increments | X | X |
| Compliance – Trip meter | X | X |
| Chronometer Odometer - cannot be reset by User | X | X |
| Pressure | | |
| User can Increase level | | |
| Before treatment | X | X |
| During treatment | | |
| User can Decrease level | | |
| Before treatment | X | X |
| During treatment | | |

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#### 510(k) Summary Page 7 of 9

| Characteristic | Normatec Elite | Normatec 3 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------|
| Treatment Mode | | |
| NormaTec Patented Pulse Algorithm | X | X |
| Treatment | | |
| Starting via button press | X | X |
| Pause via button press | X | X |
| Un-pause via button press | X | X |
| End - If timer reaches 0:00⁰⁰, treatment will<br>continue until Rest period is reached. | X | X |
| Remote operation via Bluetooth app | X | X |
| Battery Charging | | |
| Control unit interface displays battery level | X | X |
| Control unit interface displays when battery is<br>charging | X | X |
| Power On/Off Button | | |
| Off mode - No treatment in process | X | X |
| On mode - Treatment is process when start button<br>also pressed. | X | X |
| Appliance type | | |
| Selection of appliance - Inflatable boot, arm or<br>hip<br>NOTE: If hip appliance is selected, treatment<br>mode defaults to 2-zone treatment<br>Note: Normatec Elite is only an inflatable<br>boot. | Boot only | Boot<br>Arm<br>Hip |

# Differences between Proposed and Predicate Device Discussion

The proposed device differs in the following ways from the predicate:

- The proposed device Normatec Elite does not contain hip or arm attachments like the proposed device -● Normatec 3 - K220217. The proposed device only offers leg attachments.
- Physical size of control unit was reduced while maintaining the same technology.
- The power supply for Normatec Elite is different than Normatec 3 K220217. ●
- External air hose was integrated into the air inflatable.

### Discussion of Differences

The differences between the proposed and predicate device do not raise any new concerns regarding the safety and effectiveness as demonstrated by performance testing.

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#### 510(k) Summary Page 8 of 9

# Substantial Equivalence Discussion

## Substantial Equivalence Discussion

The table above compares the key features of the proposed device with the identified predicate - Normatec 3 -K220217. The comparison demonstrates that the proposed device can be found to be substantially equivalent to the predicate device.

## Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate device. Discussion - The indications for use are identical.

### Technology and construction -

The technology and principle of operation is identical for the proposed device when compared to the predicate device.

Discussion - Both the proposed and predicate device have identical principles of operation.

# Environment of Use -

The environments of use are similar to predicate, which are clinics, hospital, athlete training, and home environments.

Discussion - The environments of use are the identical.

# Patient Population -

The patient population is adults. Discussion - The proposed and predicate device patient populations are identical.

# Non-Clinical Testing Summary -

# Bench testing -

Performance testing demonstrated that the proposed device met its acceptance criteria. Testing included:

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

Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria.

# Biocompatibility -

The materials utilized in the proposed device are identical to the listed predicate as they were approved in their respective 510(k)s and their relationship to the patient for the proposed device are identical in formation, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.)

Discussion - The proposed device was found to meet the applicable requirements for biocompatibility safety for the intended population.

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# Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.