510(k) K130644
K130644 is an FDA 510(k) premarket notification submitted by Columbia Medical Mfg, LLC for the device "PEDIATRIC FOLDING WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on Oct 16, 2013. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2013
- Date Received
- Mar 11, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stroller, Adaptive
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type
- 510(k)