510(k) K260319
- Device
- 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))
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- 510(k) number
- K260319
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-31
- Date received
- 2026-01-30
- Regulation
- 890.3850
- Classification name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Ying Mei
- Address
- #799, Chuqiao Rd., Zhenjiang City, Jiangsu Province,China Zhenjiang CN
FDA Registration Numbers
- 3014810929
- 3003832369
- 8022752
- 1221084
- 3011707750
- 3011059051
- 3005905321
- 3016969129
- 3010461764
- 3038189860
- 3033814356
- 3007289408
- 3011714211
- 3015772781
- 3007160937
- 3005858417
- 2022883
- 9616881
- 3009265647
- 3016601021
- 3005555653
- 3007309323
- 3004013215
- 3010394125
- 3005720080
- 3021027216
- 3044085583
- 3011669224
- 3031658417
- 3011422356
- 3036714922
- 3004577612
- 3007120364
- 9616091
- 3004194020
- 3006534178
- 3007912863
- 3007608806
- 3009407891
- 3010273872
- 3004473024
- 8043392
- 3016678950
- 3013538349
- 1531186
- 3004149089
- 9681827
- 3003781173
- 3023189540
- 3009235818
- 3004141004
- 3003162820
- 3011134213
- 3011687503
- 2081283
- 9615543
- 1000252066
- 3007019343
- 3004034546
- 2131358
- 2183191
- 3043237012
- 9618009
- 3009235796
- 3043748437
- 3023141620
- 2429947
- 1422443
- 3011475060
- 3012316249
- 3012986146
- 3004111085
- 3009302777
- 3008058406
- 1058397
- 3014293077
- 3019505063
- 3044470904
- 3007675960
- 2029329
Source Documents
Other 510(k) Records For Product Code IOR
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026-01-12 |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025-11-04 |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025-01-10 |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | 2024-10-24 |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | 2024-07-11 |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | 2024-07-05 |