# K212918: Heat StimPlus

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Co., Ltd.
- Decided: Dec 13, 2021 after 90 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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 5.

## Indications for use
The Heat StimPlus, Model FDES115 is intended TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arn) and lower extremities (leg)due to strain from exercise or normal household work activities. EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K212918
Methodology: https://510kreport.com/methodology