510(k) K241374
K241374 is an FDA 510(k) premarket notification submitted by Anhui Jbh Medical Apparatus Co., Ltd. for the device "Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code IOR (Wheelchair, Mechanical), a Class I device regulated under 21 CFR 890.3850. Anhui Jbh Medical Apparatus Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2025
- Date Received
- May 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type
A mechanical wheelchair is a manually 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/or require an assistive device for mobility.