510(k) K260145
- Device
- YJ-K1K2 Wheelchair (YJ-013F)
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- 510(k) number
- K260145
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-15
- Date received
- 2026-01-20
- Regulation
- 890.3850
- Classification name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mei Ying
- Address
- #297, Chuqiao Rd. Zhenjiang City CN 212016 212016
FDA Registration Numbers#
- 1417592
- 3007608806
- 3003162820
- 1531186
- 2437956
- 3010461764
- 3039359026
- 3032618
- 9616091
- 3007309323
- 3007160937
- 3009235818
- 3009683397
- 3030410174
- 3011134213
- 3009425497
- 1058397
- 9681827
- 3013538349
- 3014273557
- 3007912863
- 3011191255
- 3015967131
- 3009302777
- 3007289408
- 3038189860
- 3005720080
- 3007499787
- 1000252066
- 3044470904
- 3014810929
- 3032597250
- 3015220328
- 3008058406
- 3009407891
- 3014293077
- 3009327812
- 3015772781
- 3010273872
- 3007518294
- 3009235796
- 3021027216
- 2131358
- 3043748437
- 3003823002
- 3011707750
- 3005905321
- 3009596133
- 3030452839
- 3019677893
- 8022752
- 2435946
- 3019505063
- 3006799874
- 3004013215
- 3004194020
- 2085336
- 2428983
- 3005260401
- 3004473024
- 3009282549
- 3011669224
- 3031658417
- 3001657382
- 2648727
- 3044085583
- 1422443
- 3012986146
- 3036714922
- 3021327432
- 1221084
- 3011422356
- 3017171467
- 3011475060
- 3011059051
- 9615543
- 3006160539
- 1423561
- 2029329
- 3004727093
Source Documents#
Other 510(k) Records For Product Code IOR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-16 |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-15 |
| K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-15 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 |
| 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 |
| 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 |