510(k) K242722

Device: Manual Wheelchair (MASY23)
Applicant: Sichuan Ast Medical Equipment Co., Ltd.
510(k) number: K242722
Product code: IOR
Decision: Substantially Equivalent (SESE)
Decision date: 2024-11-22
Date received: 2024-09-10
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: Mae Tse
Address: #58 Jinpeng Rd., Area C, W. Industrial Park, Luxian County Luzhou CN 646100 646100

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
8043392
3004013215
3009302777
3010273872
3007675960
3004141004
3003832369
3023141620
3044470904
2429947
3042370483
1422443
3032597250
1221084
3005858417
3043460907
3007499787
3013538349
3009265647
3004034546
3005905321
1931307
3033506545
9616091
3016734231
8022752
3014421917
3007019343
3009235818
3006799874
3007912863
3011707750
3011059051
3009235796
3004111085
3008058406
3015967131
3014293077
3003162820
3021327432
2085336
3039359026
2081283
1000252066
3016601021
3006534178
2022883
1000292485

Source Documents

510(k) summary PDF

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
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
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