510(k) K030882
K030882 is an FDA 510(k) premarket notification submitted by R82 A/S for the device "RABBIT MOBILE STANDING FRAME". The FDA issued a decision of Substantially Equivalent on April 4, 2003. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. R82 A/S has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2003
- Date Received
- March 20, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type