510(k) K111636
- Device
- REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
- Applicant
- GUNNELL, INC.
- 510(k) number
- K111636
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-03
- Date received
- 2011-06-13
- 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
- ANDREW EVANCHO
- Address
- 8440 State P.O. Box 308 Millington MI US 48746 48746
FDA Registration Numbers#
- 3009327812
- 3009425497
- 3043749706
- 3004496806
- 3009235818
- 3008058406
- 1422443
- 3011687503
- 3008771621
- 3011714211
- 3016601021
- 3012986146
- 3016440583
- 3003162820
- 3009282549
- 2437956
- 3004141004
- 1000292485
- 2428983
- 1931307
- 3010461764
- 3005905321
- 3004111085
- 3004034546
- 2183191
- 2029329
- 3011059051
- 3012316249
- 2022883
- 3011669224
- 2085336
- 3005260401
- 9616091
- 1531186
- 3003123807
- 3011191255
- 3009407891
- 3005555653
- 3006799874
- 3010273872
- 3015058854
- 3023189540
- 3016678950
- 3039359026
- 2429947
- 3007912863
- 3038189860
- 3007518294
- 3007608806
- 3010394125
- 3007499787
- 3003823002
- 3015967131
- 3036714922
- 3016734231
- 3011134213
- 3009302777
- 3007019343
- 3004013215
- 3004577612
- 3001657382
- 9616881
- 3043237012
- 3021327432
- 3019677893
- 2435946
- 3007160937
- 3031658417
- 3017171467
- 1417592
- 3043460907
- 3014273557
- 2081283
- 3009596133
- 3032597250
- 3011707750
- 3014421917
- 9681827
- 3019505063
- 3005150489
Source Documents#
Other 510(k) Records For Product Code IOR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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