Clearance Summary
CONTROLLED PASSIVE MOTION MACHINE received FDA 510(k) clearance under submission number K920860, sponsored by U.S. Mfg. & Management, 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 1992-04-02.
- Submission: K920860
- Applicant / Sponsor: U.S. Mfg. & Management, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1992-04-02
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.