Clearance Summary
RABBIT MOBILE STANDING FRAME received FDA 510(k) clearance under submission number K030882, sponsored by R82 A/S. 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 2003-04-04.
- Submission: K030882
- Applicant / Sponsor: R82 A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 2003-04-04
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.