Clearance Summary
ACCUFLEX DYNAMIC ELBOW ORTHOSIS received FDA 510(k) clearance under submission number K926391, sponsored by Regulatory & Marketing Services, 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 1993-07-22.
- Submission: K926391
- Applicant / Sponsor: Regulatory & Marketing Services, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1993-07-22
Classification & Regulation
This clearance is catalogued under FDA product code IQI and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.