# K070299: Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)

- Pathway: 510(k) (Traditional)
- Applicant: Ezfit Technology, Inc.
- Decided: Jul 16, 2007 after 166 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912178 (1991). 12 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023231: Elfcare Device, Models 314A Through 314G, Mediseb, Ltd. (2003) Summary page 1.
- K052182: Shian Jia Meei Two Channel Digital T.E.N.S., Shian Jia Meei Enterprise Co., Ltd. (2005) Summary page 3.

## Most influential descendants
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (2017), 25 descendants of its own
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K211403: HIVOX OTC Electrical Stimulator, FT610-B (2021), 3 descendants of its own

## 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 sTemporary relief of minor aches and pains and muscle spasms

Source page: https://510kreport.com/device/K070299
Methodology: https://510kreport.com/methodology