Clearance Summary
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 received FDA 510(k) clearance under submission number K212377, sponsored by Ningbo Medkinetic Medical Device Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-04-15.
- Submission: K212377
- Applicant / Sponsor: Ningbo Medkinetic Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2022-04-15
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.