Clearance Summary
BIOPHYSIOMETER POSITIONING CHAIR received FDA 510(k) clearance under submission number K912320, sponsored by Bi-Dynamics, 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 1991-08-22.
- Submission: K912320
- Applicant / Sponsor: Bi-Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3110
- Decision date: 1991-08-22
Classification & Regulation
This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.