510(k) K051387
K051387 is an FDA 510(k) premarket notification submitted by Levo AG for the device "LEVO COMFORT II". The FDA issued a decision of Substantially Equivalent on June 10, 2005. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Levo AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2005
- Date Received
- May 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type