Clearance Summary
JAPANESE HOTZIE received FDA 510(k) clearance under submission number K811803, sponsored by Consolidated Health & Sports Prod.. 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 1981-07-31.
- Submission: K811803
- Applicant / Sponsor: Consolidated Health & Sports Prod.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 1981-07-31
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.