510(k) K921084
K921084 is an FDA 510(k) premarket notification submitted by Rehab Technology, Inc. for the device "THE EXCELSIOR". The FDA issued a decision of Substantially Equivalent on April 7, 1992. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Rehab Technology, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1992
- Date Received
- March 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type