Clearance Summary
OB HELP ARM received FDA 510(k) clearance under submission number K830842, sponsored by Lic-Orthion. 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 1983-04-05.
- Submission: K830842
- Applicant / Sponsor: Lic-Orthion
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1983-04-05
Classification & Regulation
This clearance is catalogued under FDA product code ILE and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.