# K200838: Tyece OTC TENS Model

- Pathway: 510(k) (Traditional)
- Applicant: Tyece Limited
- Decided: Aug 12, 2020 after 134 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: 1 generation back to K130802 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060), Shenzhen Dongdixin Technology Co., Ltd. (2013) Summary page 4.

## Indications for use
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K200838
Methodology: https://510kreport.com/methodology