For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for · symptomatic relief and management of chronic intractable pain.
For Powered heating therapy , ezFit Digital Heating TENS (Model No .; HR-661/ UC-101) is intended for

· Temporary relief of minor aches and pains and muscle spasms

Device Description

ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) ( Transcuntaneus Electrical Nerve Stimulator) is designed for symptomatic relief and management of chronic intractable pain.
ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is of independent two channels output (double output), the user can choose to use a single channel connecting to two electrode pads or using both channels with four electrode pads simultaneously. With large LCD panel. It is powered by 3.6V(1.2V x 3)Ni-H Rechargeable Batteries or AC-DC adaptor.
The ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is a TENS (Transcuntaneus Electrical Nerve Stimulator) that employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer (Powered heating pads - 21 CFR 890.5740) and conventional TENS - 21 CFR 882.5890) therapy.
When used in either Compress heat function only or Compress heat function plus TENS , An electronically controlled thermoelectric electrode pads can provide automatic thermal control with a Range of 36℃ - 42℃ . The Dual output can be adjusted to provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes as therapeutic heating. This automatic thermal control mechanism also avoid skin from thermal injury.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the ezFit Digital Heating TENS device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study design, and ground truth establishment is not explicitly detailed in the summary.

General Interpretation of the Document:

The acceptance criteria for a 510(k) submission are generally that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "study that proves the device meets the acceptance criteria" in this context is the comparison made to the predicate devices and the bench testing performed.

Here's an attempt to extract and infer the requested information based on the provided text, with explicit notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Predicate Equivalence & Standards)	Reported Device Performance (as stated or inferred)
For TENS Function:
Symptomatic relief and management of chronic intractable pain.	Same intended use as predicate TENS devices.
Electrical output characteristics (waveform, intensity, frequency).	"Waveform & output Study performed" (Details not provided).
Safety standards (electrical, electromagnetic compatibility).	Conforms to IEC 60601-1, IEC 60601-1-2.
For Powered Heating Function:
Temporary relief of minor aches and pains and muscle spasms.	Same intended use as predicate heating pads.
Automatic thermal control functionality.	Electronically controlled thermoelectric electrode pads provide automatic thermal control.
Temperature range.	Range of 36℃ - 42℃.
Therapeutic heating maintenance (duration).	Provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes.
Avoidance of thermal injury.	Automatic thermal control mechanism also avoids skin from thermal injury.
Safety standards (thermal, electrical).	Conforms to IEC 60601-1, IEC 60601-1-2. Also ISO 14971 (risk management).
General Device Characteristics:
Software validation.	"Software Validation Study performed."
Overall safety and effectiveness.	Bench testing demonstrates no new safety or effectiveness questions compared to predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of a clinical study with human subjects. The studies mentioned are:

"Software Validation Study"
"Waveform & output Study"
"Skin temperature study"

These appear to be bench tests rather than clinical performance studies on human subjects, so a "test set" in the typical AI/medical imaging sense is not applicable here.
The data provenance, if referring to these bench tests, would be internal laboratory data generated by the manufacturer. These would be retrospective data in the sense that the studies were performed prior to submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided as the submission focuses on bench testing and substantial equivalence, not a clinical study involving expert interpretation of data or images. Ground truth, if applicable to these bench tests, would be established by validated measurement equipment and engineering specifications, not human experts.

4. Adjudication Method for the Test Set

This information is not provided as it pertains to human interpretation/adjudication in clinical studies, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is a TENS unit with heating capabilities, not an AI-assisted diagnostic or therapeutic imaging device involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable. The device itself is a therapy device (TENS and heating pad), not an algorithm or AI system where "standalone" performance would be measured in the typical sense. Its performance is evaluated through bench testing against its specifications and safety standards.

7. The Type of Ground Truth Used

The ground truth for the "Software Validation Study," "Waveform & output Study," and "Skin temperature study" would be based on:

Engineering specifications and validated measurement equipment for parameters like waveform characteristics, electrical output, and temperature.
Safety standards (ISO 14971, IEC 60601-1, IEC 60601-1-2) indicating acceptable ranges and performance criteria.

It is not based on expert consensus, pathology, or outcomes data from clinical trials.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is not an AI/machine learning system that requires a "training set" in the typical sense of data used to train a model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reasons as point 8.

Summary

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K070299
JUL 16 2007

510(K) SUMMARY

Prepared Date: June 21,2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1. Submitter's Name:	ezFit Technology, Inc.
Address:	No. 42, Section 3, Chang Shi Road, An Nan District, TAINAN City , 709TAIWAN
Phone:	+886-6-2557158
Fax:	+886-6-2557159
Contact:	Mr. OU YANG / Vice President
2. Device Name :
Trade Name:	ezFit Digital Heating TENS (Model No.: HR-661/UC-101)
Common Name:	TENS unit
Classification name	Transcutaneous Electrical Nerve Stimulator (21CFR 882.5890)Powered heating pads (21 CFR 890.5740)
3. DEVICE CLASS	ezFit Digital Heating TENS (Model No.: HR-661) have been classified as• Transcutaneous Electrical Nerve Stimulation Device,Regulatory Class: IIProduct Code: GZJRegulation Number: 21CFR 882.5890• Powered heating pad,Regulatory Class: IIProduct Code: IRTRegulation Number: 21CFR 890.5740
4. Predicate Device:	The predicate device is the• ELFcare (K023231), model no.: 314A, 314B, 314C, marketed byMediseb Ltd.• SHIAN JIA MEEI TWO Channel Digital T.E.N.S (K052182)marketed by SHIAN JIA MEEI ENTERPRISE CO., LTD.
5. Device Description:	ezFit Digital Heating TENS(Model No.: HR-661/ UC-101)( Transcuntaneus Electrical Nerve Stimulator) is designed forsymptomatic relief and management of chronic intractable pain.ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is ofindependent two channels output (double output), the user can chooseProduct: ezFit Digital Heating TENS(Model No.: HR-661/ UC-101)
Page 1 of 3	Section 4 - 510(k) Summary REV. [C3]

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to use a single channel connecting to two electrode pads or using both channels with four electrode pads simultaneously. With large LCD panel. It is powered by 3.6V(1.2V x 3)Ni-H Rechargeable Batteries or AC-DC adaptor.

The ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is a TENS (Transcuntaneus Electrical Nerve Stimulator) that employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer (Powered heating pads - 21 CFR 890.5740) and conventional TENS - 21 CFR 882.5890) therapy.

When used in either Compress heat function only or Compress heat function plus TENS , An electronically controlled thermoelectric electrode pads can provide automatic thermal control with a Range of 36℃ - 42℃ . The Dual output can be adjusted to provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes as therapeutic heating. This automatic thermal control mechanism also avoid skin from thermal injury.

Model No. description

HR-661/UC-101 is all the same except the Housing printing artwork , model no. & destination.

1. Intended Use: For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for · symptomatic relief and management of chronic intractable pain.
  For Powered heating therapy , ezFit Digital Heating TENS (Model No .; HR-661/ UC-101) is intended for
· Temporary relief of minor aches and pains and muscle spasms
1. Performance The device conforms to applicable standards includes ISO 14971, IEC Summary: 60601-1, IEC 60601-1-2 and related standard.

Software Validation Study , Waveform & output Study & Skin temperature study are performed to demonstrate the safety and effectiveness of the device.

Product: ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) Page 2 of 3 Section 4 - 510(k) Summary REV. (C3)

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8. Conclusions:

The ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) has the same intended use and similar technological characteristics as the ELFcare (K023231) , model no. : 314A, 314C , marketed by Mediseb Ltd. & SHIAN JIA MEEI TWO Channel Digital T.E.N.S (K052182) marketed by SHIAN JIA MEEI ENTERPRISE CO., LTD. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is substantially equivalent to the predicate devices.

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Image /page/3/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 image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EzFit Technology, Inc. C/O Thomas Huang Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607

JUL 16 2007

Re: K070299

Trade/Device Name: ezFit Digital Heating TENS (Model #: HR-661/UC-101) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator (TENS) Regulatory Class: Class II Dated: June 28, 2007 Received: July 2, 2007

Dear Mr. Huang:

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 for assession 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 I cannal controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or subject to 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 I loase of advisou that I Drivisation that your device complies with other requirements of the Act that I DA has made a acteriminations administered by other Federal agencies. You must or any I oderar the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements of ); good manufacturing practice requirements as set

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Page 2 -- Mr. Thomas Huang

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vo

Fse

Mark N. Melkerson Director Division of General, Restorative and Neurological 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: ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) ezFit Technology, Inc.

Indications For Use:

For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for

· Symptomatic relief and management of chronic intractable pain.

For powered heating therapy, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for

• Temporary relief of minor aches and pains and muscle spasms

Prescription Use(Part 21 CFR 801 Subpart D)	V
	AND/OR
	Over-The-Counter Use(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	1070259
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Page 1 of 1

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).