Clearance Summary
PHYSICAL MEDICINE & REHABILITATION EQUIP received FDA 510(k) clearance under submission number K822906, sponsored by I-Rep, 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 1982-10-15.
- Submission: K822906
- Applicant / Sponsor: I-Rep, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5370
- Decision date: 1982-10-15
Classification & Regulation
This clearance is catalogued under FDA product code ION and 21 CFR 890.5370, within the Physical Medicine review panel as a Class I device.