Pulse 2.0, Pulse Pro 2.0
Device Facts
| Record ID | K183169 |
|---|---|
| Device Name | Pulse 2.0, Pulse Pro 2.0 |
| Applicant | NormaTec Industries, LP |
| Product Code | IRP · Physical Medicine |
| Decision Date | Dec 27, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
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.
Device Story
Powered inflatable tube massagers; simulate manual kneading/stroking via inflatable pressure cuffs. Input: user-selected settings (time, intensity/pressure) via device interface or Bluetooth-connected smartphone app. Operation: microprocessor-controlled compressor and valve system sequentially inflates appliance segments. Output: pneumatic massage therapy. Used in clinics, hospitals, athlete training, and home environments by patients. App mimics device interface; does not alter therapy or unlock features. Benefits: temporary muscle pain relief and increased circulation.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, verification, and validation activities demonstrating performance, functionality, and reliability consistent with the predicate device.
Technological Characteristics
Powered inflatable tube massager; 15 VDC power supply (IEC 60601-1) or internal Li-ion battery (IEC 62133). Materials: 200 denier nylon with polyurethane laminate. Pressure range: 0-110 mmHg. Connectivity: Bluetooth. Standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, ANSI C63.27-2017. Microprocessor-controlled sequential inflation/deflation (Sequential Gradient, Peristaltic, Pulsing).
Indications for Use
Indicated for adults in good health for temporary relief of minor muscle aches/pains and temporary increase in circulation to treated areas.
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 Pulse and Pulse Pro (K160608)
Submission Summary (Full Text)
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December 27, 2018
NormaTec Industries. LP % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K183169
Trade/Device Name: Pulse 2.0. Pulse Pro 2.0 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: December 21, 2018 Received: December 26, 2018
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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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 and Part 809); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
Device Name Pulse 2.0, Pulse Pro 2.0
Indications for Use (Describe)
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.
| 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
| 480 Pleasant Street<br>Suite A200<br>Watertown MA 02472 | Tel – 800.355.0960<br>Fax – 866.279.2579 |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------|
| Official Contact: | Albert G Sanford, Quality Systems and Regulatory Manager |
| Proprietary or Trade<br>Name: | Pulse 2.0 and Pulse Pro 2.0 |
| Common/Usual Name: | Powered inflatable tube massager (Pulse 2.0 and Pulse Pro 2.0) |
| Classification Code and 21 CFR 890.5650 Powered Inflatable tube massager<br>Name: | Product Code: IRP<br>Class II |
| Device Name: | Pulse 2.0, Pulse Pro 2.0 |
| Predicate Device: | K160608 – NormaTec Pulse and Pulse Pro |
# Device Description
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are powered inflatable tube massagers (Product Code "IRP"). They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by the use of an inflatable pressure ouff. 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-compliant lithium-ion battery.
The user interface on the Pulse Pro 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse 2.0 model is 4.3" color LCD screen with smart switches. There is no difference in function between the two interface technologies, they are offered for marketing differentiation and user preferences. The user interface provides for:
- . Starting and stopping the massage treatment;
- . Adjusting time and intensity (pressure) of the treatment.
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 Bluetooth app mimics the device interface graphics and buttons. allowing the user to use a compatible Android or iOS phone to control device functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide or unlock any additional features or alter the therapy provided by the device.
#### Intended User
OTC
#### Patient Population
Adults
#### 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.
#### Intended Use Environment:
Clinics, hospital, athlete training, and home environments.
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| Model Name<br>510(k) Number | Predicate Devices | Proposed New Devices | Comment |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| NormaTec Pulse and Pulse Pro<br>510(k) K160608 | NormaTec Pulse 2.0 and Pulse Pro 2.0<br>510(k) TBD | N/A | |
| Manufacturer | NormaTec Industries, LP | Same | N/A |
| Prescriptive<br>Indications for use | No, OTC<br>The NormaTec Pulse and Pulse Pro<br>are air pressure massagers intended to<br>temporarily relieve minor muscle aches<br>and/or pains, and to temporarily<br>increase circulation to the treated<br>areas. | Same | N/A |
| Intended Use<br>Environment | Clinics, hospital, athlete training, and<br>home environments | Same | N/A |
| Power Source(s) | 15 VDC via an IEC 60601-1<br>compliant power supply (100-240 VAC<br>input)<br>Integrated rechargeable battery | Same | N/A |
| Software / Firmware<br>Micro-processor<br>Control | Microprocessor | Same | N/A |
| Technology | Compressor and valve system that<br>sequentially inflates cells of appliance | Compressor and valve system that<br>sequentially inflates cells of appliance.<br>Bluetooth communication ability | Proposed devices incorporate a<br>certified Bluetooth module to allow<br>using a NormaTec app as a user |
| | Predicate Devices | Proposed New Devices | Comment |
| Compliance with<br>Voluntary standards | ES 60601-1, IEC 60601-1-2, IEC<br>60601-1-11 | ES 60601-1, IEC 60601-1-2, IEC<br>60601-1-11, and ANSI C63.27-2017. | The proposed devices comply with one<br>additional standard: ANSI C63.27-2017 |
| Device Pressure<br>Range | 0-110 mmHg | Same | N/A |
| Treatment Time | Stays on until the user turns it off or<br>can be set up to turn off in a range of<br>10 minutes to continuous | Same | N/A |
| Inflation/Deflation<br>Cycle Type | Sequential Gradient, Peristaltic and<br>Pulsing | Same | N/A |
| Appliance Contact<br>Surface Material | 200 denier nylon with a polyurethane<br>laminate/extrusion | Same | N/A |
| Number of Inflatable<br>appliance segments | 5 or less | Same | N/A |
| Weight | 3.6 pounds (incl. battery) | Same | N/A |
| Dimensions<br>(W x H x D) | 4" x 5" x 9" | 4.4" x 3.8" x 8.1" | N/A |
| Housing Materials<br>and Constructions | Molded ABS enclosure (94V0) | Same | N/A |
| Patient contact | Non-conductive appliances | Same | N/A |
Table 5.1 – Table of Device Comparisons and Differences
Premarket Notification 510(l
Section 5 – 510(k) Summar
NormaTec Pulse 2.0 and Pulse Pro 2.0
Page 5.2
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lormaTec Pulse 2.0 and Pulse Pro 2.0
Premarket Notification 510(k)
Section 5 – 510(k) Summary
Page 5.3
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## Differences Between Models
| Characteristic | Pulse 2.0 | Pulse Pro 2.0 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|---------------|
| Power On – The system recalls and displays the last used settings for: | X | X |
| Treatment time | X | X |
| Treatment mode | X | X |
| Therapy mode | | |
| Rehab mode - Recalls zone focus | X | X |
| Custom - recalls all settings | | |
| Recovery Flush | | |
| Appliance Type | N/A | X |
| Power Level | X | X |
| Number of zones | X | X |
| Rest time | X | X |
| Time | | |
| Add time | | |
| Before treatment | X | X |
| During treatment | | |
| Decrease time | | |
| Before treatment | X | X |
| During treatment | | |
| Continuous mode | X | X |
| Counter | | |
| Count down - 1 second increments | X | X |
| Count up (continuous mode) – 1 second increments | | |
| Compliance - Trip meter – reset by User | N/A | X |
| Chronometer Odometer – cannot be reset by User | X | X |
| Pressure | | |
| Increase level | | |
| Before treatment | X | X |
| During treatment | | |
| Decrease level | | |
| Before treatment | X | X |
| During treatment | | |
| Characteristic | Pulse 2.0 | Pulse Pro 2.0 |
| Treatment Mode – Can ONLY be changed before treatment begins | | |
| NormaTec Pulse | X | X |
| Sequential | X | X |
| Rest Time | | |
| View or change rest time - before treatment | X | X |
| # of Zones | | |
| Change number of zones – before treatment | X | X |
| Treatment | | |
| Starting | X | X |
| Pause | X | X |
| Un-pause | X | X |
| End – If timer reaches 0:0000, treatment will continue until Rest period<br>is reached. The user is given options to either:<br>Add time<br>Continue until cycle is finished<br>Quit | 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<br>NOTE: If hip appliance is selected, treatment mode defaults to 2-zone<br>treatment | X | X |
| Therapy Mode | | |
| Recovery Flush<br>Preset NormaTec PULSE time / PULSE pressure values<br>Appliance type applicable - boot, arm, hip | N/A | X |
| Rehab<br>Preset NormaTec PULSE time / PULSE pressure values<br>Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad<br>Arm appliance – Hand/wrist, forearm, elbow, bicep, shoulder<br>Hip appliance – Quadriceps, hip | N/A | X |
| Characteristic | Pulse 2.0 | Pulse Pro 2.0 |
| Custom Settings<br>Allows user to program NormaTec PULSE pressure and time values for<br>each zone<br>Pressure range – 30-110 mmHg, user can select in 10 mmHg<br>increments<br>Time range – 15 seconds to 4 minutes, user can select in 15 second<br>increments | N/A | X |
| Display Settings Adjustment | | |
| Brightness controls | N/A | X |
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## Determination of Substantial Equivalence
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are substantially equivalent to currently marketed and cleared devices (K160608) because:
### Indications for Use
The NormaTec Pulse 2.0 and Pulse Pro 2.0 indications for use are identical to the predicate, NormaTec Pulse and Pulse Pro, 510(k) K160608.
#### Prescriptive
The NormaTec Pulse 2.0, Pulse Pro 2.0, and the predicate (K160608) are OTC devices.
#### Design, Technology, and Principle of Operation
The NormaTec Pulse 2.0 and Pulse Pro 2.0 have equivalent design and features when compared to the predicate and have similar technology to the predicate, NormaTec Pulse and Pulse Pro 510(k) K160608.
The proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app mimics the device interface graphics and buttons, allowing the user to use a compatible Android or iQS phone to control device functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide or unlock any additional features or alter the therapy provided by the device.
#### Performance and Specifications
The NormaTec Pulse 2.0 and Pulse Pro 2.0 have equivalent specifications of performance when compared to the predicate, NormaTec Pulse and Pulse Pro 510(k) K160608.
#### Compliance with Standards
The predicate devices are compliant with AAMI ANSI ES6060-1. IEC 60601-1-2. and IEC 60601-1-11.
The NormaTec Pulse 2.0 and Pulse Pro 2.0 comply with AAMI ANSI ES6060-1, IEC 60601-1-11, and ANSI C63.27-2017.
#### Materials
The patient-contacting materials of the NormaTec Pulse 2.0 are the inflatable appliances that are identical to the predicate, NormaTec Pulse and Pulse Pro 510(k) K160608.
#### Intended Use Environment
Clinics, hospital, athlete training, and home environments, which are identical to the predicate.
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### Features
The NormaTec Pulse 2.0 and Pulse Pro 2.0 have equivalent features when compared to the predicate, NormaTec Pulse and Pulse Pro 510(k) K160608.
## Conclusion
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are substantially equivalent to the predicate, NormaTec Pulse and Pulse Pro 510(k) K160608 in:
- Patient population, o
- . Environment of use.
- Technology characteristics, .
- Materials, ●
- Specifications / performance, and ●
- Compliance with international standards. o
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 Pulse 2.0, Pulse Pro 2.0 Indications for Use and Contraindications are identical to the predicate NormaTec Pulse and Pulse Pro 510(k) K160608.
Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the NormaTec Pulse 2.0 and Pulse Pro 2.0 with respect to the predicate were performed. Testing performed demonstrated that the proposed devices meet defined requirements and performance claims.
