Clearance Summary
FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE received FDA 510(k) clearance under submission number K926262, sponsored by Sgarlato Laboratories, 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 1994-01-26.
- Submission: K926262
- Applicant / Sponsor: Sgarlato Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1994-01-26
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.