510(k) K071390
K071390 is an FDA 510(k) premarket notification submitted by Innovative Products, Inc. for the device "WHEELCHAIR MODEL STS". The FDA issued a decision of Substantially Equivalent on July 20, 2007. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Innovative Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2007
- Date Received
- May 18, 2007
- Clearance Type
- Abbreviated
- 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