K233067
- 510(k) number
- K233067
- Device name
- Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
- Applicant
- Chongqing Rob Linka Science and Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-07-19
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.