Clearance Summary
THERA-PAK received FDA 510(k) clearance under submission number K780452, sponsored by Hydro-Med Products, Inc.. 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 1978-06-21.
- Submission: K780452
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5720
- Decision date: 1978-06-21
Classification & Regulation
This clearance is catalogued under FDA product code ILO and 21 CFR 890.5720, within the Physical Medicine review panel as a Class II device.