K Number
K160323
Device Name
FlowKeepers
Date Cleared
2017-04-06

(426 days)

Product Code
Regulation Number
890.5850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powered Muscle Stimulator - · To temporarily increase local blood circulation in healthy leg muscles. - · To stimulate healthy muscles in order to improve and facilitate muscle performance. TENS - · For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.
Device Description
The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher.
More Information

No
The summary describes a standard electrical muscle stimulator and TENS device with no mention of AI/ML features, training data, or performance metrics typically associated with AI/ML.

Yes
The device is described as providing temporary relief of pain associated with sore and aching muscles, which is a therapeutic effect. It also aims to improve and facilitate muscle performance and increase local blood circulation, which can be considered therapeutic in nature.

No
Explanation: The "Intended Use / Indications for Use" section indicates that the device is a "Powered Muscle Stimulator" and "TENS" (Transcutaneous Electrical Nerve Stimulation) device for therapeutic purposes such as increasing blood circulation, stimulating muscles for performance, and temporary pain relief. It does not mention any function related to diagnosing medical conditions.

No

The device description explicitly states it is a "portable, battery powered device" that "delivers electrical stimulation through the skin to the muscles" and includes a "control unit with power buttons and LED flasher," indicating it is a hardware device.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Function: The description clearly states that this device delivers electrical stimulation through the skin to muscles. It's a non-invasive device that interacts directly with the body's tissues.
  • Intended Use: The intended uses are related to stimulating muscles and relieving pain, which are therapeutic or physiological effects, not diagnostic testing of bodily specimens.
  • Lack of IVD Indicators: There is no mention of analyzing samples, using reagents, or any other activities typically associated with IVD devices.

Therefore, the FlowKeepers® device, as described, falls under the category of a therapeutic or physiological device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Powered Muscle Stimulator

  • To temporarily increase local blood circulation in healthy leg muscles.
  • To stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS

  • For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.

Product codes (comma separated list FDA assigned to the subject device)

NGX, NUH

Device Description

The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

leg muscles, lower extremities (legs)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Performance Testing
Electromagnetic compatibility, electrical safety testing, and other performance testing were conducted in accordance with the following standards
IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment Part 1: General requirements for safety
IEC 60601-1-2 Edition 3: 2007-03 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility- Requirements and tests
IEC 60601-1-11 Edition 1.0 2010-04
Medical electrical equipment Part 1-11: General Requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators.
In all instances, the FlowKeepers® functioned as intended and the results observed were as expected.

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.

K143207, K140650

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.

K160508

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

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2017

DK Electronics, LLC Avery Huff Operations Mgr 413-B Elmwood Ave, Sharon Hill, Pennsylvania 19079

Re: K160323

Trade/Device Name: FlowKeepers® Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: February 22, 2017 Received: March 7, 2017

Dear Avery Huff:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -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) K160323

Device Name FlowKeepers®

Indications for Use (Describe)

Powered Muscle Stimulator - To temporarily increase local blood circulation in healthy leg muscles

  • To stimulate healthy muscles in order to improve and facilitate muscle performance

TENS

  • For temporary relief of pain associated with sore and aching muscles of the lower extremities (legs) due to strain from exercise or normal household and work activities
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary K160323

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter:DK Electronics, LLC
Submitter Address:413-B Elmwood Ave, Sharon Hill, PA 19079
Phone:855-494-5158
Facsimile:484-494-5163
Contact Person:Avery Huff
Email:avery_huff@yahoo.com
Date Prepared:4/6/2017

Trade Name and Classification of Device

Trade Name of Device:FlowKeepers®
Common Name:Powered Muscle Stimulator
Neuromuscular electrical stimulator devices (NMES)
Classification:Powered Muscle Stimulator (21 CFR 890.5850)
Product Codes:Primary - NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
Secondary - NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
Review Panel:Physical Medicine

Predicate Devices

Revitive IX® (OTC), Actegy Ltd. (K143207) – NGX, NUH 21 CFR 890.5850 Pennypad PP-904 Rapid Relief™ (OTC), HiVox Biotek, Inc. (K140650) – NUH, 21 CFR 890.5890

Intended Use/ Indications for Use

Powered Muscle Stimulator

  • · To temporarily increase local blood circulation in healthy leg muscles.
  • · To stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS

  • · For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.

Device Description

The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher. To see how FlowKeepers® technological characteristics are similar to the predicate device, see the comparison chart below under the Substantial Equivalence heading.

Performance Testing

Electromagnetic compatibility, electrical safety testing, and other performance testing were conducted in

4

accordance with the following standards

IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment Part 1: General requirements for safety

IEC 60601-1-2 Edition 3: 2007-03 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility- Requirements and tests

IEC 60601-1-11 Edition 1.0 2010-04

Medical electrical equipment Part 1-11: General Requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators.

In all instances, the FlowKeepers® functioned as intended and the results observed were as expected.

Substantial Equivalence

The FlowKeepers® is substantially equivalent to other powered muscle stimulators such as Revitive IX® OTC (K143207). The FlowKeepers® has the same intended uses and similar indications, technological characteristics, and principles of operation as the Revitive IX® OTC. The difference in design and the minor technological differences between the FlowKeepers® and its predicate device Revitive IX® OTC raise no new issues of safety or effectiveness. Performance data demonstrate that the FlowKeepers® is as safe and effective as the predicate device. Thus, the FlowKeepers® is substantially equivalent.

5

Comparison of FlowKeepers® with Revitive IX® (OTC) and

HiVox Biotek, Inc. Rapid ReliefTM Pennypad PP-904 (OTC)

| | DK Electronics, LLC
FlowKeepers® | Actegy Ltd.
Revitive IX®
(OTC) | HiVox Biotek, Inc.
Rapid Relief™
Pennypad PP-904 (OTC) | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 510(k) Number | K160323 | K143207 | K140650 | |
| Product Codes:
Model | NGX, NUH
FlowKeepers® | NGX, NUH
RIX | NUH
PP-904 | |
| Indications for Use (IFU) | Powered Muscle Stimulator:
-Temporarily increase local
blood circulation in healthy leg
muscles.
-To stimulate healthy muscles
in order to improve and
facilitate muscle performance.
TENS
-Temporary relief of pain
associated with sore and aching
muscles in the lower extremities
(legs) due to strain from
exercise, normal household
duties and work activities. | To temporarily increase local
blood circulation in healthy
leg muscles.

To stimulate healthy muscles
in order to improve and
facilitate muscle performance.
For temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, upper
extremities (arms) and lower
extremities (legs) due to strain
from exercise or normal
household duties. | The Rapid Relief Pennypad
PP-904 is indicated for
temporary relief of pain
associated with sore and
aching muscles in the upper
and lower extremities (arm
and/or leg), and lower back
due to strain from exercise or
normal household and work
activities. | |
| Dimensions (mm) [WxHxD] | 140.6 mm x 67.14 mm x 10.5
mm | Ø360 mm x 75 mm | 113 mm x 70 mm x 9.7 mm | |
| Waveform | Pulsed symmetrical biphasic and
bipolar | Pulsed symmetrical biphasic,
rectangular and bipolar | Symmetrical biphasic | |
| Shape | Rectangular | Not Available | Rectangular | |
| Power Source(s) | DC 3 V Li Ion battery CR2032 | DC 5V | DC 3 V Li Ion battery
CR2032 | |
| Number of Output Modes | 1 | 1 | 1 | |
| Number of Output Channels | 1 | 2 (1 for Foot, 1 for body pads) | 1 | |
| Automatic Shut Off | Auto Shut off at 10 hrs, low
battery | Automatic Shut off, Override
Control | Automatic Shut off at 60
minutes, low battery | |
| Automatic Overload Trip | No | Not Available | No | |
| Automatic No-Load Trip | Yes | Not Available | No | |
| Patient Override Control | Yes | Yes | Yes | |
| Software/Firmware/Micropr
ocessor Control | Yes | Yes | Yes | |
| Weight | 0.6 oz (with electrodes)
0.8 oz (with electrodes +
battery) | 1725 g (not including PSU) | 13g (with battery) | |
| Regulated Voltage Level | Yes | Not Available | Yes | |
| Regulated Current Level | No | Not Available | No | |
| Timer Range (minutes) | 600 minutes ±10% | 1 to 60 min | 15 minutes | |
| Indicator Display:
On/Off Status | LED
Power On/Off, Level up/down | Not available | Power On | |
| Low Battery | Red LED | | | |
| Voltage/Current Level | Level 1-15 | | | |
| Compliance with Voluntary
Standards | UL 60601-1, EN60601-1-2,
EN 60601-1-11, EN60601-2-10
EN ISO 13485 | MDD (93/42EEC), EN
60601-1,
EN60601-1-2, EN 60601-1-
11,
EN60601-2-10 | EN 60601-1,EN60601-1-2,
EN60601-2-10
EN ISO 13485 | |
| Compliance with 21 CFR
898* | Yes | Yes | Yes | |
| Housing Materials and
Construction | Casing/body ABS + PET,
contacts NBR | Casing/body ABS, footpads
NBR | Casing/body ABS Medical
Grade Silicon, contacts | |
| | | DK Electronics, LLC
FlowKeepers® | Actegy Ltd.
Revitive IX® (OTC) | HiVox Biotek, Inc.
Rapid ReliefTM
Pennypad PP-904 (OTC) |
| Maximum
output voltage
(V) (±20%) | @ 500 Ω
@ 2 kΩ
@ 10 kΩ | 166V
252V
290V | 32V
Not Available
Not Available | 57.6V
89.6V
96.0V |
| Maximum
output current
(±20%) | @ 500 Ω
@ 2 kΩ
@ 10 kΩ | 332mA
126mA
29mA | 10-14mA
Not Available
Not Available | 115.2mA
44.8mA
9.6mA |
| Pulse Duration (µs) | | 150 µs +150 µs ±10% | Not Available | 200 µs |
| Frequency (Hz) | | 100mHz ±10% | 20-53Hz | 2, 5, 40 Hz |
| Net Charge per Pulse (µC) | | 0 @500Ω | Not Available | 2304 @500Ω |
| Maximum Phase Charge (µC) | | 2.25 @500Ω | Not Available | 23.04 @500Ω |
| Maximum Current Density
(mA/cm²) | | 0.789 mA@500Ω | Not Available | 2.828 @500Ω |
| Maximum Power Density (