510(k) K103212
- Device
- ROUGHRIDER
- Applicant
- WHIRLWIND WHEELCHAIR INTERNATIONAL
- 510(k) number
- K103212
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-03
- Date received
- 2010-11-01
- 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
- No
Applicant Contact#
- Contact
- MARC KRIZACK
- Address
- 1600 Holloway Ave. Sci 251 San Francisco CA US 94132 94132
FDA Registration Numbers#
- 8022752
- 9616091
- 3003781173
- 3030410174
- 2183191
- 2022883
- 2029329
- 3003832369
- 3023189540
- 3010394125
- 2937137
- 3032597250
- 3033506545
- 3007675960
- 3016440583
- 3016734231
- 2131358
- 3009683397
- 3039359026
- 3006799874
- 3009235818
- 3015058854
- 3031658417
- 3005905321
- 2648727
- 3014293077
- 3012986146
- 3019505063
- 3012316249
- 3001657382
- 3011422356
- 3019677893
- 3044085583
- 9618009
- 3007120364
- 1417592
- 3033814356
- 9681827
- 3007019343
- 2435946
- 3044470904
- 3007309323
- 3005555653
- 1058397
- 1531186
- 3008058406
- 2429947
- 3007518294
- 3009407891
- 3003823002
- 9615543
- 3011059051
- 3004034546
- 2531465
- 3009327812
- 2428983
- 3013538349
- 3008771621
- 3009235796
- 3004473024
- 3011475060
- 3005260401
- 3043460907
- 3009596133
- 1422443
- 3003123807
- 3036714922
- 3004013215
- 3015220328
- 3032618
- 3004577612
- 3009302777
- 3010273872
- 3005858417
- 3011687503
- 3004727093
- 8043392
- 3004149089
- 2081283
- 3003162820
Source Documents#
Other 510(k) Records For Product Code IOR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| K252828 | Manual Wheelchair (W47) | 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases