# K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Mar 10, 2021 after 93 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: 8 generations back to K940301 (1994). 26 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 31 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.
- K190347: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2019) Summary page 5.

## Most influential descendants
- K223308: Heating Tens/Ems, FT-810R (2023), 0 descendants of its own
- K221251: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) (2022), 0 descendants of its own
- K213091: Well-Life TENS/EMS/Heating Stimulator (2022), 0 descendants of its own
- K212918: Heat StimPlus (2021), 0 descendants of its own

## Indications for use
HIVOX OTC Electrical Stimulator, EM59-1 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 (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. SH: This function is designed to be used for temporary relief of minor aches and pains. HIVOX OTC Electrical Stimulator, EM59-2 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 (arm) 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. SH: This function is designed to be used for temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K203574
Methodology: https://510kreport.com/methodology