510(k) K252517
- Device
- Manual Wheelchair (SYIV100A008)
- Applicant
- Ningbo Shenyu Medical Equipment Co.,Ltd
- 510(k) number
- K252517
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-03
- Date received
- 2025-08-11
- Regulation
- 890.3850
- Classification name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Song Zhenyong
- Address
- #1318 W. Of Tanjialing Rd. Yuyao CN 315400 315400
FDA Registration Numbers
- 3009282549
- 3004496806
- 9615543
- 3003123807
- 3017171467
- 3004727093
- 3004194020
- 1531186
- 3011714211
- 3007160937
- 3001657382
- 3011422356
- 3043749706
- 3007120364
- 3030452839
- 3043237012
- 3004149089
- 3003781173
- 3019677893
- 2648727
- 3009407891
- 3010461764
- 3005260401
- 3016440583
- 3004577612
- 3007608806
- 3005150489
- 2183191
- 3019505063
- 3010394125
- 3011475060
- 3004473024
- 3012316249
- 3014810929
- 3008771621
- 3043748437
- 3038189860
- 3015772781
- 2937137
- 2428983
- 3005555653
- 3008723825
- 3003823002
- 3032618
- 3005720080
- 3012986146
- 9618009
- 3011134213
- 3021027216
- 2437956
- 3011191255
- 3023189540
- 3016969129
- 1417592
- 1058397
- 3007518294
- 3011687503
- 3009327812
- 9616881
- 3011669224
- 3033814356
- 9681827
- 3031658417
- 3007289408
- 3009596133
- 3036714922
- 2029329
- 2131358
- 2531465
- 3014273557
- 1423561
- 3009425497
- 3016678950
- 3030410174
- 3015220328
- 3015058854
- 3007309323
- 2435946
- 3009683397
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code IOR
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 |
| K260319 | 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)) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 |
| 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 |
| 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 |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 |