Clearance Summary
TOE LOOPS received FDA 510(k) clearance under submission number K780194, sponsored by Orthopedic Equipment Co., 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 1978-02-14.
- Submission: K780194
- Applicant / Sponsor: Orthopedic Equipment Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3910
- Decision date: 1978-02-14
Classification & Regulation
This clearance is catalogued under FDA product code KNO and 21 CFR 890.3910, within the Physical Medicine review panel as a Class I device.