Clearance Summary
FLEXION MITTENS received FDA 510(k) clearance under submission number K771030, sponsored by Stat Medical Corp.. 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 1977-06-27.
- Submission: K771030
- Applicant / Sponsor: Stat Medical Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5350
- Decision date: 1977-06-27
Classification & Regulation
This clearance is catalogued under FDA product code IOD and 21 CFR 890.5350, within the Physical Medicine review panel as a Class I device.