Clearance Summary
HUCHEL BODYLINER received FDA 510(k) clearance under submission number K873576, sponsored by Hans-Juergen Huchel. 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 1988-01-19.
- Submission: K873576
- Applicant / Sponsor: Hans-Juergen Huchel
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5740
- Decision date: 1988-01-19
Classification & Regulation
This clearance is catalogued under FDA product code IRT and 21 CFR 890.5740, within the Physical Medicine review panel as a Class II device.