510(k) K091578
K091578 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "LIFT CHAIR, MODEL T3". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Pride Mobility Products Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2009
- Date Received
- June 2, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Positioning, Electric
- Device Class
- Class II
- Regulation Number
- 890.3110
- Review Panel
- PM
- Submission Type