# K190009: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

- Pathway: 510(k) (Traditional)
- Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
- Decided: Dec 2, 2019 after 333 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 K912178 (1991). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121719: SM Tens & PMS, Hong Qiangxing (Shenzhen) Electronics Limited (2013) Summary page 6.
- K143430: SmartTENS, Easy Med Instrument Co., Ltd. (2015) Summary page 6.
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device), Bayer Healthcare, LLC (2015) Summary page 9.

## Indications for use
Model SM9187: TENS (Mode 1, 3, 4, 5, 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model SM9180L & SM9180S: TENS (Mode 1, 3, 4, 5, 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K190009
Methodology: https://510kreport.com/methodology