510(k) K020933
K020933 is an FDA 510(k) premarket notification submitted by Garaventa Accessibility for the device "GARAVENTA SUPER-TRAC TRE-52". The FDA issued a decision of Substantially Equivalent on April 4, 2002. The device falls under product code ING (Elevator, Wheelchair, Portable), a Class II device regulated under 21 CFR 890.3930. Garaventa Accessibility has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2002
- Date Received
- March 22, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Wheelchair, Portable
- Device Class
- Class II
- Regulation Number
- 890.3930
- Review Panel
- PM
- Submission Type
A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).