K250360
- 510(k) number
- K250360
- Device name
- TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
- Applicant
- Shenzhen Jiantuo Electronics Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-05-11
- Date received
- 2025-02-10
- 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: K250360
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.