# K223308: Heating Tens/Ems, FT-810R

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: May 13, 2023 after 197 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: 9 generations back to K940301 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2, Hivox Biotek, Inc. (2021) Summary page 4.
- K211403: HIVOX OTC Electrical Stimulator, FT610-B, Hivox Biotek, Inc. (2021) Summary page 4.

## Indications for use
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Source page: https://510kreport.com/device/K223308
Methodology: https://510kreport.com/methodology