K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))
K260319 is the FDA 510(k) clearance record for K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)), a class I device, cleared for Zhenjiang Assure Medical Equipment Co., Ltd. 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 7 510(k) clearances for Zhenjiang Assure Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K260319.
Clearance record
- Decision date
- Received
- (60 days to decision)
- Product code
- IOR Wheelchair, Mechanical
- Regulation
- 21 CFR 890.3850
- Device class
- Class I
- Review panel
- Physical Medicine
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd. #799, Chuqiao Rd., Zhenjiang City, Jiangsu Province,China, Zhenjiang, CN
- 510(k) summary
- Summary PDF
- 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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