510(k) K780183
- Device
- WHEELCHAIRS, MECHANICAL
- Applicant
- ORTHOPEDIC EQUIPMENT CO., INC.
- 510(k) number
- K780183
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-02-13
- Date received
- 1978-02-03
- Regulation
- 890.3850
- Classification name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2435946
- 3015058854
- 9616091
- 3042370483
- 3007675960
- 3043460907
- 3036714922
- 3044085583
- 3007019343
- 9616881
- 2428983
- 3009235796
- 3011714211
- 3043748437
- 3011687503
- 3043749706
- 3015220328
- 2183191
- 3016601021
- 2085336
- 3004727093
- 3016734231
- 3007499787
- 3006799874
- 3005260401
- 8043392
- 3007120364
- 3007608806
- 3009235818
- 1221084
- 3012316249
- 3007160937
- 3015772781
- 3005858417
- 3003832369
- 3001657382
- 2029329
- 1058397
- 9681827
- 3023141620
- 1000292485
- 3007912863
- 1417592
- 3010394125
- 3044470904
- 3032597250
- 3009265647
- 3009302777
- 3013538349
- 3014273557
- 3043237012
- 3004577612
- 3004034546
- 3011191255
- 3016969129
- 2937137
- 3003162820
- 3008723825
- 3011475060
- 2531465
- 3021327432
- 3039359026
- 3004111085
- 3010461764
- 3005555653
- 9618009
- 1931307
- 3009407891
- 3006160539
- 3005150489
- 3019505063
- 3003823002
- 3011059051
- 3011889389
- 3023189540
- 3032618
- 3011781238
- 3009327812
- 3010273872
- 3007289408
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | 2026-09-22 |
| 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 |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | 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 |
Legacy Summary#
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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