Clearance Summary
LIMB ORHTOSIS received FDA 510(k) clearance under submission number K810222, sponsored by Medical Design & Manufacturing 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 1981-02-04.
- Submission: K810222
- Applicant / Sponsor: Medical Design & Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1981-02-04
Classification & Regulation
This clearance is catalogued under FDA product code ITQ and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.