K Number

Device Name

Pulse Rx 2.0, Pulse Pro Rx 2.0

Manufacturer

NormaTec Industries, LP

Date Cleared

2018-12-21

(21 days)

Product Code

JOW

Regulation Number

870.5800

Intended Use

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

Device Description

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161346

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical compression.

Therapeutic

Yes
The device is intended to treat specific medical conditions such as lymphedema, venous insufficiency, and to prevent Deep Vein Thrombosis, indicating its therapeutic purpose.

Diagnostic

No
Explanation: The device description and intended use indicate it applies pressure to treat various edematous conditions and prevent DVT. It does not mention any function for identifying, analyzing, or diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it includes "Compressible Limb Sleeves" and is powered by an "external IEC 60601-1 Power Supply" and an "internal IEC 62133-compliant lithium-ion battery," indicating significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes applying pressure to the extremities to treat various conditions like lymphedema and venous insufficiency. This is a therapeutic application, not a diagnostic one.
Device Description: The device is described as "Compressible Limb Sleeves" that simulate manual kneading and stroking. This is a physical therapy/rehabilitation type of device, not one that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectomy lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

Product codes

JOW

Device Description

The user interface on the Pulse Pro Rx 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse Rx 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

Extremities

Indicated Patient Age Range

Adults

Intended User / Care Setting

Home, hospital, and other healthcare settings.

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 Rx 2.0 and Pulse Pro Rx 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)

K161346

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 21, 2018

NormaTec Industries, LP % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313

Re: K183328

Trade/Device Name: Pulse Rx 2.0, Pulse Pro Rx 2.0 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: November 27, 2018 Received: November 30, 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 mav, 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.

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Fernando Aguel Fernando Aguel -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

K183328

Device Name Pulse Rx 2.0, Pulse Pro Rx 2.0

Indications for Use (Describe)

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: Iymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

Type of Use (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 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 Rx 2.0 and Pulse Pro Rx 2.0 |
| Common/Usual Name: | Compressible limb sleeve |
| Classification Code and
Name: | 21 CFR 870.5800 Compressible Limb Sleeve
Product Code: JOW
Class II |
| Device Name: | Pulse Rx 2.0, and Pulse Rx 2.0 |
| Predicate Device: | K161346 – NormaTec PCD-B and NormaTec PCD-T |

Device Description

Starting and stopping the massage treatment; .
. Adjusting time and intensity (pressure) of the treatment.

Intended User

Rx Only

Patient Population

Adults

Indications for Use

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves intended to apply pressure to the extremities to treat Lymphedema and other edematous conditions, including:

Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) .
Post-mastectomy lymphedema .
Post-infection lymphedema •
Post-traumatic lymphedema .
Post-surgical lymphedema .
Post-radiation-treatment lymphedema .
Venous insufficiency .
Venous stasis ulceration .

and to prevent Deep Vein Thrombosis

Intended Use Environment:

Home, hospital, and other healthcare settings.

Table 5.1 – Table of Device Comparisons and Differences

	Predicate Devices	Proposed New Devices	Comment
Model Name
510(k) Number	NormaTec PCD-B and NormaTec PCD-T 510(k) K161346	NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 510(k) TBD	N/A
Manufacturer	NormaTec Industries, LP	Same	N/A
Prescriptive	Yes	Same	N/A
Indications for use	The NormaTec PCD-B and PCD-T are
compressible limb sleeves intended to
apply pressure to the extremities to treat
Lymphedema and other edematous
conditions, including:
Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema Venous insufficiency Venous stasis ulceration and to prevent Deep Vein Thrombosis	Same	N/A
Intended Use
Environment	Home, hospital, and other healthcare
settings.	Same	N/A
Power Source(s)	15 VDC via an IEC 60601-1
compliant power supply (100- 240 VAC
input).
Optional internal battery.	15 VDC via an IEC 60601-1
compliant power supply (100- 240 VAC
input).
Integrated rechargeable battery	N/A
	Predicate Devices	Proposed New Devices	Comment
Software / Firmware
Micro-processor
Control	Microprocessor	Same	N/A
Technology	Compressor and valve system that
sequentially inflates cells of appliance	Compressor and valve system that
sequentially inflates cells of appliance.
Bluetooth communication ability.	Proposed devices incorporate a certified
Bluetooth module to allow using a
NormaTec app as a user interface.
Compliance with
Voluntary standards	ES 60601-1, IEC 60601-1-2, IEC 60601-
1-11	ES 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
Range	Same	Same	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 to
175 minutes	Stays on until the user turns it off or can
be set up to turn off in a range of 10
minutes to continuous	N/A
Inflation/Deflation
Cycle Type	Sequential Gradient, Peristaltic and
Pulsing	Same	N/A
Appliance Contact
Surface Material	200 denier nylon with a polyurethane
laminate/extrusion	Same	N/A
Number of Inflatable
appliance segments	5 or less	Same	N/A
Weight	3.6 pounds (incl. battery)	Same	N/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 Constructions	Molded ABS enclosure (94V0)	Same	N/A
Patient contact	Non-conductive appliances	Same	N/A

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

NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0

Differences Between Models

Characteristic	Pulse Rx 2.0	Pulse Pro Rx 2.0
Power On - The system recalls and displays the last used settings for:
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

Section 5 - 510(k) Summary

Characteristic	Pulse Rx 2.0	Pulse Pro Rx 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
is reached. The user is given options to either:
Add time
Continue until cycle is finished
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
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	N/A	X
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	N/A	X
Characteristic	Pulse Rx 2.0	Pulse Pro Rx 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
increments	N/A	X
Display Settings Adjustment
Brightness controls	N/A	X

Determination of Substantial Equivalence

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are substantially equivalent to currently marketed and cleared devices NormaTec PCD-B and NormaTec PCD-T 510(k) K161346 because:

Indications for Use

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 indications for use are identical to the predicate device, NormaTec PCD-B and NormaTec PCD-T 510(k) K161346.

Prescriptive

The NormaTec Pulse Rx 2.0, Pulse Pro Rx 2.0, and the predicate (K161346) are Rx devices.

Design, Technology, and Principle of Operation

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent design and features when compared to the predicate and have the equivalent technology to the predicate. NormaTec PCD-B and NormaTec PCD-T 510(k) K161346.

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 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.

Performance and Specifications

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent specifications of performance when compared to the predicate. NormaTec PCD-B and PCD-T 510(k) K161346.

Compliance with Standards

The predicate devices are compliant with AAM ANSI ES60601-1-2, and IEC 60601-1-11.

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 comply with AAMI ANSI ES60601-1. IEC 60601-1-2. IEC 60601-1-11, and ANSI C63.27-2017.

Materials

The patient-contacting materials of the Pulse Rx 2.0 and Pulse Pro Rx 2.0 are the inflatable appliances that are identical to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346.

Intended Use Environment

Home, hospital, and other healthcare settings, which are identical to the predicate.

Features

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 have equivalent features when compared to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346.

Conclusion

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are substantially equivalent to the predicate, NormaTec PCD-B and PCD-T 510(k) K161346 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 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 Rx 2.0 and Pulse Pro Rx 2.0 Indications for Use and Contraindications are identical to the predicate device, NormaTec PCD-T and NormaTec PCD-B 510(k) K161346.