(65 days)
K220217 – Normatec 3
No
The description details a standard air pressure massager with user-controlled settings and Bluetooth connectivity for app control. There is no mention of AI/ML in the device description, intended use, or performance studies. The device's functionality appears to be based on pre-programmed pressure cycles and user inputs, not adaptive or learning algorithms.
Yes.
The device is intended to temporarily relieve minor muscle aches and/or pains and increase circulation, which are therapeutic claims.
No
Explanation: The device is described as an "air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." Its function is therapeutic (massage and circulation) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states it is a "powered inflatable tube massager" with physical components like buttons, a display, a power supply, and a battery, indicating it is a hardware device with accompanying software.
Based on the provided information, the Normatec Elite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." This is a therapeutic and physical function, not a diagnostic one.
- Device Description: The device is described as an "air pressure massager" that "simulates manual kneading of tissues." This aligns with a physical therapy or recovery device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Anatomical Site: The device is applied externally to the legs. IVDs typically involve analyzing samples taken from within the body.
- Performance Studies: The performance studies focus on bench testing of controls, indicators, battery, and hazard mitigations, as well as biocompatibility. These are typical for medical devices that interact with the body externally, not for IVDs which focus on analytical performance.
In summary, the Normatec Elite is a therapeutic device designed for external physical application, not a diagnostic device that analyzes samples to provide information about a patient's health status.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Treated areas (muscle aches and/or pains) - implied to be areas where the inflatable cuff can be applied. Specifically "5 segments for leg attachment" is mentioned.
Indicated Patient Age Range
Adults
Intended User / Care Setting
OTC
Clinics, hospital, athlete training, and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key results: 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.)
Key results: The proposed device was found to meet the applicable requirements for biocompatibility safety for the intended population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K220217 – Normatec 3
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221666 – Normatec Go
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Expiration Date: 07/31/2026 See PRA Statement below.
Form Approved: OMB No. 0910-0120
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
NormaTec Industries, LP
| Date of Preparation: | January 15, 2024 |
|---|---|
| 480 Pleasant Street | |
| Suite A200 | |
| Watertown MA 02472 | Tel - 800.355.0960 |
| Fax - 866.279.2579 | |
| Official Contact: | Steve Henderson, Director of Quality & Regulatory Systems |
| Proprietary or Trade | |
| Name: | Normatec 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 | |
| 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 | |
| Speciality: | Physical Medicine |
5
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.
6
510(k) Summary Page 3 of 9
Table 1 – Table of Device Comparisons and Differences
| | Proposed Device
Normatec Elite | Predicate Device
Normatec 3 – K220217 | Reference Device
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
pressure massager intended to
temporarily relieve minor muscle
aches and/or pains, and to
temporarily increase circulation to
the treated areas. | The Normatec 3 is an air
pressure massager intended to
temporarily relieve minor
muscle aches and/or pains, and
to temporarily increase
circulation to the treated areas. | The Normatec Go is an air
pressure massager intended to
temporarily relieve minor
muscle aches and/or pains, and
to temporarily increase
circulation to the treated areas. | Identical |
| Anatomical
Coverage | Control unit mounted to inflatable
segment with integral hoses.
Image: Normatec Elite device | Control unit connected to
inflatable segments via a hose.
Image: Normatec 3 device | Control unit mounted to
inflatable segment with integral
hoses.
Image: Normatec Go device | The proposed device has a smaller
control unit version of predicate
device, which eliminates the hose
and mounting the control unit
directly on the inflatable patient
part.
The reference device is included
only to demonstrate that FDA has
previously cleared a NormaTec
device with a similar control unit
mounted directly to the device
itself. |
| 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 |
| | Proposed Device
Normatec Elite | Predicate Device
Normatec 3 - K220217 | Reference Device
Normatec Go – K221666 | Comment |
| Power Source(s) | 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 | Charging via 5 VDC
compliant power supply (100-
240 VAC input)
Powered by integrated
rechargeable battery | Similar
Normatec Elite and Normatec 3
are operational when plugged into
the power supply, though Elite has
a different power supply. |
| 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 |
| Device Pressure
range | 0 - 110 mm Hg | 0 - 110 mm Hg | 0 – 220 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 - 70 mm Hg
Level 2: 60 - 90 mm Hg
Level 3: 80 - 110 mm Hg
Level 4: 100 - 140 mm Hg
Level 5: 130 - 170 mm Hg
Level 6: 150 - 200 mm Hg
Level 7: 180 - 220 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 |
| | Proposed Device
Normatec Elite | Predicate Device
Normatec 3 – K220217 | Reference Device
Normatec Go – K221666 | 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 | 5 segments for leg attachment | 5 segments for leg attachment
2 segments for hip attachment
5 segments for arm attachment | 3 | Identical
Normatec Elite does not contain a
hip or arm attachments. |
| Weight | 3.0 lbs | 3.6 lbs | 1.2 lbs | Similar |
| Control Unit
Dimensions
(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
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 (