Clearance Summary
Tyece OTC EMS System, Model EM35 received FDA 510(k) clearance under submission number K172241, sponsored by Tyece , 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 2017-11-20.
- Submission: K172241
- Applicant / Sponsor: Tyece , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2017-11-20
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.