(166 days)
Not Found
No
The description focuses on standard TENS and heating therapy functionalities with electronic controls, and there is no mention of AI or ML terms or concepts.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "symptomatic relief and management of chronic intractable pain" and "Temporary relief of minor aches and pains and muscle spasms," which are therapeutic applications. Additionally, the device description mentions it employs TENS therapy and provides therapeutic heating for pain relief.
No
The device is described as a TENS (Transcutaneous Electrical Nerve Stimulator) and heating device intended for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly details hardware components such as rechargeable batteries, an AC-DC adaptor, electrode pads, and a large LCD panel, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Transcutaneous Electrical Nerve Stimulation" and "Powered heating therapy" for pain relief and muscle spasms. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a TENS device with heating capabilities. It describes electrical stimulation and thermal transfer applied to the skin. This is consistent with a physical therapy or pain management device, not a device 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 disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IRT
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.
Model No. description
HR-661/UC-101 is all the same except the Housing printing artwork , model no. & destination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Software Validation Study , Waveform & output Study & Skin temperature study are performed to demonstrate the safety and effectiveness of the device.
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.
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.
Not Found
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
§ 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).
0
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 , 709 |
| TAIWAN | |
| 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: II | |
| Product Code: GZJ | |
| Regulation Number: 21CFR 882.5890 | |
| • Powered heating pad, | |
| Regulatory Class: II | |
| Product Code: IRT | |
| Regulation Number: 21CFR 890.5740 | |
| 4. Predicate Device: | The predicate device is the |
| • ELFcare (K023231), model no.: 314A, 314B, 314C, marketed by | |
| Mediseb 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 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
Product: ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) |
| Page 1 of 3 | Section 4 - 510(k) Summary REV. [C3] |
1
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.
-
- 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
- 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.
-
· Temporary relief of minor aches and pains and muscle spasms
-
- 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)
2
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.
3
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
4
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
5
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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