(30 days)
K183169 – NormaTec Pulse 2.0 and Pulse Pro 2.0
Not Found
No
The summary describes a device with basic user controls and Bluetooth connectivity for app control, but there is no mention of AI or ML algorithms being used for treatment adjustments, data analysis, or personalized therapy. The "Not Found" entries for AI/ML mentions and training/test data descriptions further support this conclusion.
Yes.
It is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation, which aligns with the definition of a therapeutic device.
No
The device is described as an air pressure massager intended to relieve muscle aches and increase circulation, not to diagnose any medical condition.
No
The device description explicitly states it is a "powered inflatable tube massager" and details hardware components like an external power supply, internal battery, buttons, and a display. While it has a companion app, the core medical device functionality resides in the physical hardware.
Based on the provided information, the Normatec 3 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to temporarily relieve minor muscle aches and increase circulation. This is a physical therapy/massage function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is an air pressure massager that simulates manual kneading and stroking. It applies external pressure to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Normatec 3 does not fit this description.
N/A
Intended Use / Indications for Use
The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches 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 3 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 powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-2 compliant lithium-ion battery.
The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:
- Starting and stopping the massage treatment; .
- Adjusting time and intensity (pressure) of the treatment; .
- Selection of Attachment in use (Leg, Arm, Hip); .
- . Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected
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 (referring to areas where the inflatable pressure cuff is applied: Leg, Arm, Hip).
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended User: OTC
Intended Use Environment: 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)
Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed. Testing performed demonstrated that the proposed device meets defined requirements and performance claims.
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.
K183169 – NormaTec Pulse 2.0 and Pulse Pro 2.0
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.
Not Found
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2022
NormaTec Industries, LP % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220217
Trade/Device Name: Normatec 3 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: January 25, 2022 Received: January 26, 2022
Dear Prithul Bom:
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. 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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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.
for Heather Dean, PhD 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
2
Indications for Use
510(k) Number (if known) K220217
Device Name Normatec 3
Indications for Use (Describe)
The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches 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: | February 22, 2022 |
|---|---|
| 480 Pleasant Street | |
| Suite A200 | |
| Watertown MA 02472 | Tel - 800.355.0960 |
| Fax - 866.279.2579 | |
| Official Contact: | Steve Henderson, Quality Systems and Regulatory Manager |
| Proprietary or Trade | |
| Name: | Normatec 3 |
| Subject Device: | Normatec 3 |
| 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: | K183169 – NormaTec Pulse 2.0 and Pulse Pro 2.0 |
| 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 |
4
Device Description
The Normatec 3 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 powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-2 compliant lithium-ion battery.
The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:
- Starting and stopping the massage treatment; .
- Adjusting time and intensity (pressure) of the treatment; .
- Selection of Attachment in use (Leg, Arm, Hip); .
- . Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected
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
ОТС
Patient Population
Adults
Indications for Use
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.
Intended Use Environment:
Clinics, hospital, athlete training, and home environments.
5
510(k) Summary Page 3 of 9
Table 1 – Table of Device Comparisons and Differences
| | Predicate Device | Proposed New Device | Comment | Characteristic | Pulse 2.0 / Pulse
Pro 2.0 | Normatec 3 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------|
| Model Name
510(k) Number | NormaTec Pulse 2.0 and Pulse Pro 2.0
510(k) K183169 | Normatec 3
510(k) K220217 | N/A | Power On - The system recalls and displays the last used settings for: | | |
| Manufacturer | NormaTec Industries, LP | Same | N/A | Treatment time | X | X |
| Prescriptive | No, OTC | Same | N/A | Treatment mode | X | N/A |
| Indications for use | The NormaTec Pulse 2.0 and Pulse
Pro 2.0 are air pressure massagers
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. | N/A | Therapy mode
Rehab mode - Recalls zone focus
Custom - recalls all settings
Recovery Flush | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | N/A |
| Intended Use
Environment | Clinics, hospital, athlete training, and
home environments | Same | N/A | Rehab
Preset NormaTec PULSE time / PULSE pressure values
Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad
Arm appliance - Hand/wrist, forearm, elbow, bicep, shoulder
Hip appliance - Quadriceps, hip | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | N/A |
| Power Source(s) | 15 VDC via an IEC 60601-1
compliant power supply (100- 240 VAC
input)
Integrated rechargeable battery | Same | N/A | Appliance Type | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | X |
| Software / Firmware
Micro-processor
Control | Microprocessor | Same | N/A | Pressure Level | X | X |
| Technology | Compressor and valve system that
sequentially inflates cells of appliance.
Bluetooth communication ability. | Same | N/A | Number of zones | X | X |
| Compliance with
Voluntary standards | AAMI ANSI ES60601-1, IEC 60601-1-
2, IEC 60601-1-11 and ANSI C63.27-
2017. | Same and includes IEC 60601-1-6
compliance | The additional testing of 60601-1-6
compliance does not raise any new
device safety concerns | Rest time | X | x |
| | Predicate Device | Proposed New Device | Comment | Time | | |
| Device Pressure
Range | 0-110 mmHg | Same | N/A | Add time
Before treatment
During treatment | X | X |
| Pressure Levels | Level 1: 40 mm Hg max
Level 2: 50 - 60 mm Hg max
Level 3: 60 - 70 mm Hg max
Level 4: 70 - 80 mm Hg max
Level 5: 80 mm Hg max
Level 6: 80 - 90 mm Hg max
Level 7: 100 mm Hg max | Same | N/A | Decrease time
Before treatment
During treatment | X | x |
| ZoneBoost | Provides an increase of 10 mm Hg to
the Zone selected | Same | N/A | Continuous mode | X | N/A |
| Treatment Time | Stays on until the user turns it off or
can be set up to turn off in a range of
10 minutes to continuous | 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 | Changed setup times for treatment of
new device to a max of 60 minutes
instead of continuous to match user
typical sessions with device. | Counter | X | X |
| Inflation/Deflation
Cycle Type | Sequential Gradient, Peristaltic and
Pulsing | Same | N/A | Count down - 1 second increments | X | X |
| Appliance Contact
Surface Material | 200 denier nylon with a polyurethane
laminate/extrusion | Same | N/A | Count up (continuous mode) - 1 second increments | X | N/A |
| Number of Inflatable
appliance segments | 5 or less | Same | N/A | Compliance - Trip meter | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | X |
| Weight | 3.6 pounds (incl. battery) | Same | N/A | Chronometer Odometer - cannot be reset by User | X | X |
| Dimensions
(W x H x D) | 4.4" x 3.8" x 8.1" | 4.17 x 3.66 x 8.25 | N/A | Pressure | | |
| Housing Materials
and Constructions | Molded ABS enclosure (94V0) | Same | N/A | | | |
| Patient contact | Non-conductive appliances | Same | N/A | | | |
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K220217
510(k) Summary
Page 4 of 9
7
Differences Between Models
8
510(k) Summary
Page 6 of 9
| Characteristic | Pulse 2.0 / Pulse
Pro 2.0 | Normatec 3 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------|
| Increase level | | |
| Before treatment | × | × |
| During treatment | | |
| Decrease level | | |
| Before treatment | × | × |
| During treatment | | |
| Characteristic | Pulse 2.0 / Pulse
Pro 2.0 | Normatec 3 |
| Treatment Mode – Can ONLY be changed before treatment begins | | |
| NormaTec Pulse | X | X |
| Sequential | X | N/A |
| Rest Time | | |
| View or change rest time – before treatment | X | N/A |
| # of Zones | | |
| Change number of zones – before treatment | X | N/A |
| Treatment | | |
| Starting | X | X |
| Pause | X | X |
| Un-pause | X | X |
| End - If timer reaches 0:0000, treatment will continue until Rest period
is reached. | X | X |
| Remote operation via Bluetooth app | X | X |
| Battery Charging | | |
| Displays battery level | X | X |
| Displays when battery is charging | X | X |
| Power off | | |
| No treatment in process | X | X |
| Treatment is process | X | X |
| Appliance type | | |
| Select appliance – boot, arm, hip
NOTE: If hip appliance is selected, treatment mode defaults to 2-zone
treatment | X | X |
| Therapy Mode | | |
| Recovery Flush
Preset NormaTec PULSE time / PULSE pressure values
Appliance type applicable - boot, arm, hip | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | N/A |
| Rehab
Preset NormaTec PULSE time / PULSE pressure values
Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad
Arm appliance - Hand/wrist, forearm, elbow, bicep, shoulder
Hip appliance - Quadriceps, hip | Pulse 2.0 – N/A
Pulse Pro 2.0 – X | N/A |
| Characteristic | Pulse 2.0 / Pulse
Pro 2.0 | Normatec 3 |
| Custom Settings
Allows user to program NormaTec PULSE pressure and time values for
each zone
Pressure range – 30-110 mmHg, user can select in 10 mmHg
increments
Time range - 15 seconds to 4 minutes, user can select in 15 second
increments | Pulse 2.0 – N/A
Pulse Pro 2.0 - Χ | N/A |
| Display Settings Adjustment | | |
| Brightness controls | Pulse 2.0 – N/A
Pulse Pro 2.0 - Χ | N/A |
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510(k) Summary Page 7 of 9
10
510(k) Summary Page 8 of 9
Determination of Substantial Equivalence
The Normatec 3 is substantially equivalent to currently marketed and cleared devices (K183169) because:
Indications for Use
The Normatec 3 indications for use are identical to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0, 510(k) K183169.
Prescriptive
The Normatec 3 and the predicate (K183169) are OTC devices.
Design, Technology, and Principle of Operation
The Normatec 3 has equivalent design and features when compared to the predicate and have similar technology to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.
The proposed device has Bluetooth capability that allows the use of a NormaTec app to control the device. In addition to the user interface on the devices, the proposed device has 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.
Performance and Specifications
The Normatec 3 has equivalent specifications of performance when compared to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.
Compliance with Standards
The predicate devices are compliant with AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017.
The Normatec 3 complies with AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017.
Materials
The patient-contacting materials of the Normatec 3 are the inflatable appliances that are identical to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.
11
Intended Use Environment
Clinics, hospital, athlete training, and home environments, which are identical to the predicate.
Features
The Normatec 3 has equivalent features when compared to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.
Conclusion
The Normatec 3 is substantially equivalent to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169 in:
- Patient population, .
- Environment of use, .
- . Technology characteristics,
- Materials, ●
- Specifications / performance, and .
- Compliance with international standards. .
The inclusion of the Bluetooth capability and associated app does not affect the equivalency of the proposed devices and the predicate. The app functions only as an alternative user interface. No additional features are provided or unlocked by the app. Nor is the therapy provided by the devices affected by using the app.
Other minor differences as detailed in the substantial equivalence table do not raise questions of safety and effectiveness.
Indications for Use
The Normatec 3 Indications for Use and Contraindications are identical to the predicate NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.
Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed. Testing performed demonstrated that the proposed device meets defined requirements and performance claims.
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as the predicate device according to 807.92(b)(3).