# K233067: Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Rob Linka Science and Technology Co., Ltd.
- Decided: Jul 19, 2024 after 297 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Over-The-Counter Use: TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. EMS/NMES: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: TENS: 1) Symptomatic relief of chronic intractable pain; 2) Post traumatic pain; 3) Post surgical pain; EMS/NMES: 1) Relaxation of muscle spasm; 2) Increase of local blood flow circulation; 3) Prevention or retardation of disuse atrophy; 4) Muscle re-education; 5) Maintaining or increasing range of motion; 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K233067
Methodology: https://510kreport.com/methodology