K232517
- 510(k) number
- K232517
- Device name
- Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
- Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2023-12-08
- Date received
- 2023-08-18
- 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: K232517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.