# K232675: Heating Tens, FT-615

- Pathway: 510(k) (Special)
- Applicant: Hivox Biotek, Inc.
- Decided: Oct 5, 2023 after 34 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: 7 generations back to K912178 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211403: HIVOX OTC Electrical Stimulator, FT610-B, Hivox Biotek, Inc. (2021) Summary page 4.

## Indications for use
The FT-615 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 relief of minor aches and pains.

Source page: https://510kreport.com/device/K232675
Methodology: https://510kreport.com/methodology