Clearance Summary
OW100S (model OW100S-US) received FDA 510(k) clearance under submission number K213120, sponsored by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. 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 2022-10-12.
- Submission: K213120
- Applicant / Sponsor: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 2022-10-12
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.