510(k) K011513
K011513 is an FDA 510(k) premarket notification submitted by Merits Health Products., Inc. for the device "MP3U, POWER WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on Aug 10, 2001. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Merits Health Products., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 2001
- Date Received
- May 16, 2001
- Clearance Type
- Abbreviated
- 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).