Akisu Folding Wheelchair, Models Aw-900, 910, 920, 930, 950 and Aw-820, 830
K951037 is the FDA 510(k) clearance record for AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830, a class I device, cleared for Akisu Machinery on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "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”...". FDA records list one 510(k) clearance for Akisu Machinery. As of , FDA records show no recalls naming K951037.
Clearance record
- Decision date
- Received
- (13 days to decision)
- Product code
- IOR Wheelchair, Mechanical
- Regulation
- 21 CFR 890.3850
- Device class
- Class I
- Review panel
- Physical Medicine
- Applicant
- Akisu Machinery # 137, Ching Niarn Rd., Tai-Chung Hsien, TW
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code IOR
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 2 |
| January 2026 | 2 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 2 |
| June 2026 | 4 |
| July 2026 | 1 |
| August 2026 | 1 |
| September 2026 | 5 |
| October 2026 | 0 |
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