# K221251: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Huakai Electronic Technology Co., Ltd.
- Decided: Jul 29, 2022 after 88 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). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 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.
- K190783: Health Expert Electronic Stimulator (model: AST-300L), Shenzhen Osto Technology Company Limited (2020) Summary page 5.

## Indications for use
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (mode 4~6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: This function is designed to be used for temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K221251
Methodology: https://510kreport.com/methodology