510(k) K043511
K043511 is an FDA 510(k) premarket notification submitted by Soleus Champ International Co., Ltd. for the device "SOLEUS POWERED WHEELCHAIR, MODEL FAD-2". The FDA issued a decision of Substantially Equivalent on Mar 14, 2005. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2005
- Date Received
- Dec 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wheelchair, Powered
- Device Class
- Class II
- Regulation Number
- 890.3860
- Review Panel
- PM
- Submission Type
- 510(k)
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).