Clearance Summary
CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE received FDA 510(k) clearance under submission number K850030, sponsored by Arc Motion , Ltd.. 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 1985-04-25.
- Submission: K850030
- Applicant / Sponsor: Arc Motion , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1985-04-25
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.