Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is described as a simple, battery-powered microcurrent device with manual settings.

Therapeutic

Yes
The device is intended for the "temporary relief of pain associated with sore and aching muscles," which constitutes a therapeutic use.

Diagnostic

No
Explanation: The device description and intended use clearly state that the device is for temporary pain relief, not for diagnosing any condition. It applies microcurrent to the body for therapeutic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Hand held, 1.5 volt AA battery powered, single mode, single function device" with an "integrated electrode," indicating it is a physical hardware device that delivers microcurrent.

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 is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
Device Description: The device applies microcurrent directly to the body. IVD devices typically analyze samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose or monitor conditions.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.

The device is a therapeutic device intended for pain relief through the application of microcurrent.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Product codes

NUH

Device Description

Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)

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)

The Quick Relax Pro has undergone biocompatibility testing of its tissue-contacting electrode in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-12. In addition, the Quick Relax Pro has undergone Product Safety testing in compliance to IEC 60601-1 and Electromagnetic Compatibility testing in compliance to IEC 60601-1-2. The results of each of the foregoing sets of test requirements were satisfactory, and serve to demonstrate the safety and effectiveness of the Quick Relax Pro.

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

Not Found

Predicate Device(s)

K121757

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

0

K131956

Section 005 – 510(k) Summary

APR 2 4 2014

.

Applicant or Sponsor Information

Name:	Healthcare Innovations, LLC
Address:	12889 Coco Plum Lane
	Naples, FL 34119-8530
Contact:	Dr. John Ricci
Phone:	(239) 593 - 9570
Fax:	(239) 593 - 9570
E-mail:	jriccirx@earthlink.net
Establishment Registration:	TBD
Date of Submission:	23 June, 2013

Submission Correspondent (Preparer's) Information

| Name: | Shepard G. Bentley, RAC
President, Bentley Biomedical Consulting, LLC
Consultant to Healthcare Innovations, LLC |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | 28241 Crown Valley Parkway
Suite 510(k)
Laguna Niguel, CA 92677 |
| Device Information | |
| Device Common Name: | Transcutaneous electrical nerve stimulator for pain relief
intended for over the counter use |
| Device Trade Name: | Quick Relax Pro |
| Device Classification Name: | Stimulator, nerve, transcutaneous, over-the -counter |

(

1

Device Class:	Class II
Product Code:	NUH
CFR Reference:	882.5890
Predicate Device	K121757	HealthmateForever®

Design and Use of the Device

Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.

Technological Characteristics Comparison

Technical Characteristics	Quick Relax Pro	HealthmateForever® Pro-8AB
Intended Use	To be used for temporary
relief of pain associated with
sore and aching muscles in
the shoulder, waist, back,
neck, upper extremities (arm),
and lower extremities (leg)
due to strain from exercise or
normal household work
activities	To be used for temporary
relief of pain associated with
sore and aching muscles in
the shoulder, waist, back,
neck, upper extremities (arm),
and lower extremities (leg)
due to strain from exercise or
normal household work
activities
Battery Powered	1.5V DC	3.7V DC
Method of Line Current
Isolation	Type BF	Type BF
Number of Output Modes	1	8
Waveform	Asymetrical Biphasic	Asymetrical Biphasic
Software	No	Yes
Functions	Single	Multiple

2

Parameter		Subject Device	Predicate Device
510(k) Number		K131956	K121757
Device Name and Model		Quick Relax Pro	HealthmateForever
Manufacturer		Healthcare
Innovations, LLC	Healthmate
International, LLC
Power Source(s)		Battery, single
AA dry cell	Battery, single dry
cell
-Method of Line Current Isolation		N/A	N/A
-Patient Leakage Current		N/A	N/A
-Normal Condition (μC)		N/A	N/A
-Single Fault Condition (µC)		N/A	N/A
Average DC current through electrodes when device is
on but no pulses are being applied (µC)		N/A (pulses
always applied
when on)	N/A (pulses always
applied when on)
Number of Output Modes		1	2
Number of Output Channels	Synchronous or
Alternating?
Method of
Channel
Isolation	N/A	N/A
Regulated Current or Regulated
Voltage?		N/A	N/A
Software/Firmware/Microprocessor Control?		No	Yes
Automatic Overload Trip?		No	No
Automatic No-Load Trip?		No	No
Automatic Shut Off?		No	No
User Override Control?		No	Yes
Indicator Display:	On/Off Status?
Low Battery?
Voltage/Current
Level?	Yes
No
Yes	Yes
Yes
Yes
Timer Range (minutes)		N/A	Yes
Compliance with Voluntary Standards?		Yes	Yes
Compliance with 21 CFR 898?		N/A	Presumed
Weight (lbs., oz.)		4.5 oz	3.9 oz
Dimensions (in) [W x H x D]		8.75" x 2" x
1.75"	3.75" x 2" x .5"
Housing Materials and Construction		Flame ret. ABS,
stainless steel	Metal, LCD
Parameter	Subject Device	Predicate Device
Mode or Program Name	Output	Pro-8AB
Waveform (e.g., pulsed monophasic, biphasic)	Pulsed biphasic (asymmetrical unbalanced)	Pulsed biphasic (asymmetrical unbalanced)
Shape (e.g., rectified, spike, rectified sinusoidal)	Rectified sinusoidal (with undershoot)	Rectangular with taper
Maximum Output Voltage (volts) (+/-5%)	58.4v @ 500Ω
220v @ 2KΩ
995v @ 10KΩ
applies measure prior to EnCadis' clarification - revised calculation is approx 300v @ 10KΩ	70v @ 500Ω
90v @ 2KΩ
100v @10KΩ
Maximum Output Current (mA) (+/- 5%)	117 mA @ 500Ω
110 mA @ 2KΩ
100 mA @ 10KΩ	140 mA @ 500Ω
45 mA @ 2KΩ
10 mA @ 10KΩ
Duration of primary (depolarizing) phase (µSec)	N/A	unknown
Pulse Duration (µSec)	11 µSec	10 mSec
Frequency (Hz)	30 Hz (max amplitude)	100 Hz
For multiphasic waveforms only:
Symmetrical phases?
Phase Duration	No

Positive Phase:
11 µSec
Negative Phase:
2 µSec (@ min amplitude, 500Ω load)
25 µSec (@ max amplitude, 10KΩ load) | No

3

:

4

Summary of Technological Characteristics Comparison

The foregoing comparison of the technological characteristics of the subject and predicate devices confirms that the devices are substantially equivalent with respect to intended uses, method of powering, physical descriptions, method of isolation and waveforms.

The differences regarding battery power, material descriptions, number of output modes, presence of software and overall numbers of functions confer an added degree of safety to the subject device.

Therefore, the subject device is at least as safe if not safer than the predicate device, and substantially equivalent with regard to the relevant comparators of the devices.

Summary of Non-Clinical Testing

The Quick Relax Pro has undergone biocompatibility testing of its tissue-contacting electrode in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-12. In addition, the Quick Relax Pro has undergone Product Safety testing in compliance to IEC 60601-1 and Electromagnetic Compatibility testing in compliance to IEC 60601-1-2. The results of each of the foregoing sets of test requirements were satisfactory, and serve to demonstrate the safety and effectiveness of the Quick Relax Pro.

The product safety, electromagnetic compatibility and biocompatibility test results provide assurance that the subject device performs as well or better than the predicate device.

5

The introduction of the Quick Relax Pro into interstate commerce does not raise any new issues of safety or effectiveness.

and the comments of the count

100 - 100 - 100 -

:

END OF 510(K) SUMMARY

6

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles an abstract caduceus or a representation of human services.

Public Health Service

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

April 24, 2014

Healthcare Innovations, LLC c/o Shepard G. Bentley, RAC Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677

Re: K131956

Trade/Device Name: Quick Relax Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 4, 2014 Received: March 25, 2014

Dear Mr. Bentley:

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

7

Page 2 - Mr. Shepard Bentley

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

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDcvices/Safety/ReportalProblem/dcfault.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,

Carlos L. Peña AS

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131956

Device Name

Quick Relax Pro

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household 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)

...

:

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

.

Carlos Pena -S

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

9

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