# K211403: HIVOX OTC Electrical Stimulator, FT610-B

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Oct 15, 2021 after 162 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 6 generations back to K912178 (1991). 15 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, Jkh Health Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K232675: Heating Tens, FT-615 (2023), 0 descendants of its own
- K223151: Nu-beca Transcutaneous Electrical Nerve Stimulation (2023), 0 descendants of its own
- K223308: Heating Tens/Ems, FT-810R (2023), 0 descendants of its own

## Indications for use
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Source page: https://510kreport.com/device/K211403
Methodology: https://510kreport.com/methodology