K Number
K183169
Device Name
Pulse 2.0, Pulse Pro 2.0
Date Cleared
2018-12-27

(41 days)

Product Code
Regulation Number
890.5650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

Not Found

No
The document describes a standard air pressure massager with basic user interface controls and a mirroring mobile app. There is no mention of adaptive algorithms, data analysis for personalized treatment, or any other features indicative of AI/ML.

Yes
The devices are "intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas," indicating a therapeutic purpose.

No

The device is described as an air pressure massager intended for temporary relief of muscle aches and pains and to increase circulation. Its function is to simulate manual kneading and stroking, not to diagnose any condition.

No

The device description clearly states it is a powered inflatable tube massager with physical components like a power supply, battery, and user interface screens, in addition to the software app.

Based on the provided information, the NormaTec Pulse 2.0 and Pulse Pro 2.0 are not IVD (In Vitro Diagnostic) devices.

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 or physical therapy type of use, not a diagnostic one.
  • Device Description: The description focuses on the mechanical action of air pressure massage and its control. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens.
    • Providing information about a disease or condition based on the analysis of biological samples.
    • Using reagents or assays.
    • Reporting results in terms of biological markers or measurements.

In summary, the NormaTec Pulse 2.0 and Pulse Pro 2.0 are devices used for physical therapy and temporary relief of muscle discomfort, not for diagnosing conditions based on in vitro analysis.

N/A

Intended Use / 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.

Product codes

IRP

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.

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 massagers are applied, such as limbs or hips, based on mentions of appliance types like boot, arm, hip, leg appliance, arm appliance)

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160608

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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).

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

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.

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 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

2

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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3

NormaTec Industries, LP

| 480 Pleasant Street
Suite A200
Watertown MA 02472 | Tel – 800.355.0960
Fax – 866.279.2579 |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------|
| Official Contact: | Albert G Sanford, Quality Systems and Regulatory Manager |
| Proprietary or Trade
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
Name: | Product Code: IRP
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.

4

| Model Name

510(k) NumberPredicate DevicesProposed New DevicesComment
NormaTec Pulse and Pulse Pro
510(k) K160608NormaTec Pulse 2.0 and Pulse Pro 2.0
510(k) TBDN/A
ManufacturerNormaTec Industries, LPSameN/A
Prescriptive
Indications for useNo, OTC
The NormaTec Pulse and Pulse Pro
are air pressure massagers intended to
temporarily relieve minor muscle aches
and/or pains, and to temporarily
increase circulation to the treated
areas.SameN/A
Intended Use
EnvironmentClinics, hospital, athlete training, and
home environmentsSameN/A
Power Source(s)15 VDC via an IEC 60601-1
compliant power supply (100-240 VAC
input)
Integrated rechargeable batterySameN/A
Software / Firmware
Micro-processor
ControlMicroprocessorSameN/A
TechnologyCompressor and valve system that
sequentially inflates cells of applianceCompressor and valve system that
sequentially inflates cells of appliance.
Bluetooth communication abilityProposed devices incorporate a
certified Bluetooth module to allow
using a NormaTec app as a user
Predicate DevicesProposed New DevicesComment
Compliance with
Voluntary standardsES 60601-1, IEC 60601-1-2, IEC
60601-1-11ES 60601-1, IEC 60601-1-2, IEC
60601-1-11, and ANSI C63.27-2017.The proposed devices comply with one
additional standard: ANSI C63.27-2017
Device Pressure
Range0-110 mmHgSameN/A
Treatment TimeStays on until the user turns it off or
can be set up to turn off in a range of
10 minutes to continuousSameN/A
Inflation/Deflation
Cycle TypeSequential Gradient, Peristaltic and
PulsingSameN/A
Appliance Contact
Surface Material200 denier nylon with a polyurethane
laminate/extrusionSameN/A
Number of Inflatable
appliance segments5 or lessSameN/A
Weight3.6 pounds (incl. battery)SameN/A
Dimensions
(W x H x D)4" x 5" x 9"4.4" x 3.8" x 8.1"N/A
Housing Materials
and ConstructionsMolded ABS enclosure (94V0)SameN/A
Patient contactNon-conductive appliancesSameN/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

5

lormaTec Pulse 2.0 and Pulse Pro 2.0

Premarket Notification 510(k)
Section 5 – 510(k) Summary

Page 5.3

6

Differences Between Models

CharacteristicPulse 2.0Pulse Pro 2.0
Power On – The system recalls and displays the last used settings for:XX
Treatment timeXX
Treatment modeXX
Therapy mode
Rehab mode - Recalls zone focusXX
Custom - recalls all settings
Recovery Flush
Appliance TypeN/AX
Power LevelXX
Number of zonesXX
Rest timeXX
Time
Add time
Before treatmentXX
During treatment
Decrease time
Before treatmentXX
During treatment
Continuous modeXX
Counter
Count down - 1 second incrementsXX
Count up (continuous mode) – 1 second increments
Compliance - Trip meter – reset by UserN/AX
Chronometer Odometer – cannot be reset by UserXX
Pressure
Increase level
Before treatmentXX
During treatment
Decrease level
Before treatmentXX
During treatment
CharacteristicPulse 2.0Pulse Pro 2.0
Treatment Mode – Can ONLY be changed before treatment begins
NormaTec PulseXX
SequentialXX
Rest Time
View or change rest time - before treatmentXX
# of Zones
Change number of zones – before treatmentXX
Treatment
StartingXX
PauseXX
Un-pauseXX
End – If timer reaches 0:0000, treatment will continue until Rest period
is reached. The user is given options to either:
Add time
Continue until cycle is finished
QuitXX
Remote operation via Bluetooth appXX
Battery Charging
Displays battery levelXX
Displays when battery is chargingXX
Power off
No treatment in processXX
Treatment is processXX
Appliance type
Select appliance – boot, arm, hip
NOTE: If hip appliance is selected, treatment mode defaults to 2-zone
treatmentXX
Therapy Mode
Recovery Flush
Preset NormaTec PULSE time / PULSE pressure values
Appliance type applicable - boot, arm, hipN/AX
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, hipN/AX
CharacteristicPulse 2.0Pulse Pro 2.0
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
incrementsN/AX
Display Settings Adjustment
Brightness controlsN/AX

7

8

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.

9

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.