# K190347: HIVOX OTC Electrical Stimulator

- Pathway: 510(k) (Special)
- Applicant: Hivox Biotek, Inc.
- Decided: Mar 15, 2019 after 29 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 K940301 (1994). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 5.

## Most influential descendants
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own
- K200694: Perfect EMS (2021), 1 descendant of its own
- K242460: Progenix Select Stim (2025), 0 descendants of its own
- K230926: Ova+ (K-OVAP-USA) (2023), 0 descendants of its own
- K223308: Heating Tens/Ems, FT-810R (2023), 0 descendants of its own

## Indications for use
HIVOX OTC Electrical Stimulator, EM49-1 – TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. HIVOX OTC Electrical Stimulator, EM49-2 – TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K190347
Methodology: https://510kreport.com/methodology