510(k) K122206
K122206 is an FDA 510(k) premarket notification submitted by Garaventa (Canada) Ltd [Dba Garaventa Lift] for the device "GARAVENTA X3 INCLINED PLATFORM LIFT". The FDA issued a decision of Substantially Equivalent on March 21, 2013. The device falls under product code PCE (Permanently Mounted Wheelchair Platform Lift), a Class II device regulated under 21 CFR 890.3930.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2013
- Date Received
- July 25, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Permanently Mounted Wheelchair Platform Lift
- Device Class
- Class II
- Regulation Number
- 890.3930
- Review Panel
- PM
- Submission Type
Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.