# K133979: TENS

- Pathway: 510(k) (Traditional)
- Applicant: Sunmas (H.K.) Trading Limited
- Decided: Aug 26, 2014 after 243 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: 4 generations back to K940301 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102598: HI-Dow-XP, Hi-Dow International, Inc. (2011) Summary page 5.

## Indications for use
It is intended to be used for temporary relief of pain associated with sore and aching muscle in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K133979
Methodology: https://510kreport.com/methodology