# K150386: Tyece OTC TENS Device

- Pathway: 510(k) (Traditional)
- Applicant: Tyece, Ltd.
- Decided: Nov 5, 2015 after 260 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: 5 generations back to K940301 (1994). 7 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132993: Counter Otc Tens Device, Counter Scientific Development (Gz), Ltd. (2014) Summary page 4.

## Most influential descendants
- K171803: HIVOX OTC Electrical Stimulator (2017), 21 descendants of its own
- K190347: HIVOX OTC Electrical Stimulator (2019), 8 descendants of its own
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own
- K202866: TENS & EMS Device (2021), 3 descendants of its own
- K213741: TENS & EMS DEVICE (Model: FM-B2403A) (2022), 1 descendant of its own

## Indications for use
The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.

Source page: https://510kreport.com/device/K150386
Methodology: https://510kreport.com/methodology