Clearance Summary
GAIT-AID ORTHOPEDIC INSOLE received FDA 510(k) clearance under submission number K874502, sponsored by Gait-Aid, 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 1987-11-30.
- Submission: K874502
- Applicant / Sponsor: Gait-Aid, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1987-11-30
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.