Normatec Elite Hip
Device Facts
| Record ID | K251905 |
|---|---|
| Device Name | Normatec Elite Hip |
| Applicant | NormaTec Industries, LP |
| Product Code | IRP · Physical Medicine |
| Decision Date | Sep 18, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Normatec Elite Hip 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 Hip is a powered inflatable tube massager for temporary relief of minor muscle aches/pains and increased circulation. Device consists of a control unit with buttons and display, connected to an inflatable hip sleeve. Input: user-selected treatment time, pressure level, and zone boost via device interface or Bluetooth-connected mobile app. Operation: internal compressor and valve system sequentially inflate/deflate cells in the hip sleeve using a patented pulse algorithm (sequential gradient, peristaltic, and pulsing). Output: mechanical massage/kneading of tissues. Used in clinics, hospitals, athlete training, and home environments by adults. Powered by internal rechargeable lithium-ion battery or external power supply. Healthcare providers/users monitor treatment via display (time, pressure, zone). Benefits: non-invasive muscle recovery and circulation support.
Clinical Evidence
Bench testing only. No clinical data. Testing included control functionality, indicators, battery state, performance, and hazard mitigations. Biocompatibility confirmed via identical materials and processing to predicate.
Technological Characteristics
Powered inflatable tube massager. Materials: 200 denier nylon with polyurethane laminate/extrusion; molded ABS enclosure (94V0). Energy: 12 VDC (external supply) and internal rechargeable Li-ion battery (IEC 62133-2). Connectivity: Bluetooth for app control. Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ANSI C63.27-2017. Pressure range: 0-110 mm Hg. Software: Microprocessor-controlled sequential inflation.
Indications for Use
Indicated for adults to temporarily relieve minor muscle aches and/or pains and temporarily 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 Elite (K240122)
Reference Devices
- Normatec 3 (K220217)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 18, 2025
NormaTec Industries, LP
% Matt Dryden
Director
ProMedic, LLC
131 Bay Point Drive NE
St. Petersburg, Florida 33704
Re: K251905
Trade/Device Name: Normatec Elite Hip
Regulation Number: 21 CFR 890.5650
Regulation Name: Powered Inflatable Tube Massager
Regulatory Class: Class II
Product Code: IRP
Dated: August 21, 2025
Received: August 21, 2025
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" (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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251905 - Matt Dryden
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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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K251905 - Matt Dryden
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Sincerely,
Tushar Bansal -S
Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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Normatec Elite Hip
Page 8 of 36
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251905 | ? |
| Please provide the device trade name(s). | | ? |
| Normatec Elite Hip | | |
| Please provide your Indications for Use below. | | ? |
| The Normatec Elite Hip is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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Normatec Elite Hip
510(k) Summary
K251905
Page 1 of 9
# NormaTec Industries, LP
Date of Preparation: June 20, 2025
480 Pleasant Street Tel – 800.355.0960
Suite A200 Fax – 866.279.2579
Watertown MA 02472
Sponsor Contact: Steve Henderson, Director of Quality & Regulatory Systems
Submission Correspondent: Matt Dryden, Esq. (ProMedic, LLC)
Proprietary or Trade Name: Normatec Elite Hip
Subject Device: Normatec Elite Hip
Common/Usual Name: Massager, Powered Inflatable Tube
Classification Name: Powered inflatable tube massager
Regulation Number: 21 CFR 890.5650
Product Code: IRP
Regulation Medical Speciality: Physical Medicine
Predicate Device: K240122 – Normatec Elite
Classification Name: Powered inflatable tube massager
Common/Usual Name: Powered inflatable tube massager
Regulation Number: 21 CFR 890.5650
Product Code: IRP
Reference Device: K220217 – Normatec 3
Classification Name: Powered inflatable tube massager
Common/Usual Name: Powered inflatable tube massager
Regulation Number: 21 CFR 890.5650
Product Code: IRP
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Normatec Elite Hip
510(k) Summary Page 2 of 9
# Device Description
The Normatec Elite Hip is a powered inflatable tube 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. It simulates manual kneading and stroking 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 Hip is a series of buttons with a small display screen to 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 Hip is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
## Intended Use Environment:
Clinics, hospital, athlete training, and home environments.
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Normatec Elite Hip
510(k) Summary
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Table 1 – Table of Device Comparisons and Differences
| | Proposed Device Normatec Elite Hip | Predicate Device Normatec Elite – K240122 | Reference Device Normatec 3 - K220217 | Comment |
| --- | --- | --- | --- | --- |
| Manufacturer | NormaTec Industries, LP | NormaTec Industries, LP | NormaTec Industries, LP | |
| Prescriptive | OTC | OTC | OTC | Identical |
| Indications for use | The Normatec Elite Hip 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 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. | The NormaTec 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. | Identical |
| Anatomical Coverage | Control unit mounted to inflatable segments with integral hoses. | Control unit mounted to inflatable segments with integral hoses. | Control unit connected to hip attachment via hose. | Identical
Normatec 3 – K220217 is listed as a reference device because it includes a hip attachment, which was not included in Normatec Elite – K240122. |
| Intended Use Environment | Clinics, hospital, athlete training, and home environments | Clinics, hospital, athlete training, and home environments | Clinics, hospital, athlete training, and home environments | Identical |
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Normatec Elite Hip
510(k) Summary
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| | Proposed Device
Normatec Elite Hip | Predicate Device
Normatec Elite – K240122 | Reference Device
Normatec 3 - K220217 | Comment |
| --- | --- | --- | --- | --- |
| Power Source(s) | 12 VDC via an IEC 60601-1
compliant power supply (100-240 VAC input)
Integrated rechargeable battery | 12 VDC via an IEC 60601-1
compliant power supply (100- 240 VAC input)
Integrated rechargeable battery | 15 VDC via an IEC 60601-1
compliant power supply (100- 240 VAC input)
Integrated rechargeable battery | Identical |
| Software / Firmware
Micro-processor
Control | Microprocessor | Microprocessor | Microprocessor | Identical |
| Technology | Compressor and valve system that sequentially inflates cells.
Bluetooth communication ability. | Compressor and valve system that sequentially inflates cells.
Bluetooth communication ability. | Compressor and valve system that sequentially inflates cells.
Bluetooth communication ability. | Identical |
| Compliance with
Voluntary
standards | AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 and ANSI C63.27-2017 | AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 and ANSI C63.27-2017 | AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 and ANSI C63.27-2017 | Identical |
| Device Pressure
range | 0 - 110 mm Hg | 0 - 110 mm Hg | 0 - 110 mm Hg | Identical |
| Pressure Levels | Level 1: 40 mm Hg
Level 2: 50 - 60 mm Hg
Level 3: 60 - 70 mm Hg
Level 4: 70 - 80 mm Hg
Level 5: 80 mm Hg
Level 6: 80 - 90 mm Hg
Level 7: 100 mm Hg | Level 1: 40 mm Hg
Level 2: 50 - 60 mm Hg
Level 3: 60 - 70 mm Hg
Level 4: 70 - 80 mm Hg
Level 5: 80 mm Hg
Level 6: 80 - 90 mm Hg
Level 7: 100 mm Hg | Level 1: 40 mm Hg
Level 2: 50 - 60 mm Hg
Level 3: 60 - 70 mm Hg
Level 4: 70 - 80 mm Hg
Level 5: 80 mm Hg
Level 6: 80 - 90 mm Hg
Level 7: 100 mm Hg | Identical |
| 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 | 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. | Identical |
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Normatec Elite Hip
510(k) Summary
Page 5 of 9
| | Proposed Device Normatec Elite Hip | Predicate Device Normatec Elite – K240122 | Reference Device Normatec 3 - K220217 | Comment |
| --- | --- | --- | --- | --- |
| Inflation/Deflation Cycle Type | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | Identical |
| Contact Surface Material | 200 denier nylon with a polyurethane laminate/extrusion | 200 denier nylon with a polyurethane laminate/extrusion | 200 denier nylon with a polyurethane laminate/extrusion | Identical |
| Number of Inflatable segments | 2 segments for Hip attachment *Hip attachment only | 5 segments for leg attachment *Leg attachment only | 5 segments for leg attachment
2 segments for hip attachment
5 segments for arm attachment | Different
Normatec 3 – K220217 is listed as a reference because it includes a similar hip attachment, which utilizes similar technology. |
| Weight | 3.0 lbs | 3.0 lbs | 3.6 lbs | Identical |
| Control Unit Dimensions (W x H x D) | 3.5” x 1.75” x 7.0” | 3.5” x 1.75” x 7.0” | 4.17” x 3.66” x 8.25” | Identical |
| Housing Materials and Construction | Molded ABS enclosure (94V0) | Molded ABS enclosure (94V0) | Molded ABS enclosure (94V0) | Identical |
| Patient contact | Non-conductive wrap
Surface Device
Intact Skin
Limited Duration (<24 hours) | Non-conductive wrap
Surface Device
Intact Skin
Limited Duration (<24 hours) | Non-conductive wrap
Surface Device
Intact Skin
Limited Duration (<24 hours) | Identical |
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Normatec Elite Hip
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 |
| 5 Zone Inflatable Leg Boot | | X |
| 2 zone Inflatable Hip Sleeve | X | |
| 7 Pressure Levels | X | X |
| Time | | |
| User can Add time
Before treatment
During treatment | X | X |
| User can Decrease time
Before treatment
During treatment | X | X |
| 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
During treatment | X | X |
| User can Decrease level
Before treatment
During treatment | X | X |
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Normatec Elite Hip
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 0:00^{00}, treatment will 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 charging | X | X |
| **Power On/Off Button** | | |
| Off mode - No treatment in process | X | X |
| On mode - Treatment is process when start button also pressed. | X | X |
## Differences between Proposed and Predicate Device Discussion
The subject device differs in the following ways from the predicate:
- The subject device contains a hip attachment only, which was not included in the predicate – Normatec Elite – K240122 (leg only).
- The reference device Normatec 3 – K220217 includes a similar hip attachment, which utilizes similar technology and identical Indications for Use.
- Predicate – Normatec Elite Software / Firmware was revised to:
- Disable RF for synchronous functionality
- Alter solenoid algorithm for 2 segments instead of 5.
- There were no other changes to the software / firmware.
- We have provided a table above outlining the similarities and differences between the subject and predicate device.
## Discussion of Differences
The software was modified in the following ways: disable RF for synchronous functionality, and altered solenoid algorithm for 2 segments instead of 5. The same software function was previously cleared in the predicate device – Normatec Elite – K240122.
The hip attachment is not a new technology or anatomical location for NormaTec devices. FDA has been previously reviewed and cleared a similar hip attachment under Normatec 3 – K220217.
The differences between the subject and predicate device do not raise any new concerns regarding the safety and effectiveness as demonstrated by performance testing.
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Normatec Elite Hip
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 Elite – K240122. 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 subject device when compared to the predicate device.
**Discussion** – The subject and predicate device have identical Indications for Use.
## Technology and construction –
The technology and principle of operation is similar for the subject device when compared to the predicate device.
**Discussion** – Subject device operation is made to fit the hip, while the predicate device operation is made to fit the leg. We have included a NormaTec device as a reference device demonstrating that FDA has previously cleared a similar device with similar technology and construction. The subject device design has changed, but the principle of operation remains similar. The performance metrics are consistent between the subject, predicate, and reference devices.
## Environment of Use –
The environments of use are identical, which are clinics, hospital, athlete training, and home environments.
**Discussion** – The environments of use are identical for the subject and predicate devices.
## Patient Population –
The patient population is adults.
**Discussion** – The subject and predicate device patient populations are identical.
# Non-Clinical Testing Summary –
## Bench testing –
Performance testing demonstrated that the subject 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 subject 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 subject device was found to meet the applicable requirements for biocompatibility safety for the
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Normatec Elite Hip
510(k) Summary Page 9 of 9
intended population.
## Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.
