K243856
- 510(k) number
- K243856
- Device name
- TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
- Applicant
- Shenzhen Astec Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-05-29
- Date received
- 2024-12-16
- 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: K243856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.