Clearance Summary
TENS and EMS Stimulator, TENS Stimulator received FDA 510(k) clearance under submission number K183074, sponsored by Astek Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-01-11.
- Submission: K183074
- Applicant / Sponsor: Astek Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2020-01-11
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.