510(k) K033125
- Device
- HANDIVIPP
- Applicant
- HANDINOR USA, INC.
- 510(k) number
- K033125
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-30
- Date received
- 2003-09-30
- 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
- BARBARA CHIPONIS
- Address
- 17610 26th Ave. N. Plymouth MN US 55447 55447
FDA Registration Numbers#
- 3015772781
- 1531186
- 3023141620
- 3010394125
- 2435946
- 3023189540
- 3005555653
- 3011707750
- 3043460907
- 3004473024
- 3019505063
- 3016601021
- 3009235818
- 2022883
- 3015967131
- 2131358
- 3004496806
- 3043749706
- 3007608806
- 3016678950
- 3011422356
- 3008058406
- 2183191
- 3008723825
- 9616881
- 3007160937
- 3010273872
- 2428983
- 3012316249
- 3003823002
- 3011475060
- 3011059051
- 2085336
- 3021027216
- 3004013215
- 1000252066
- 3007019343
- 3004149089
- 3016734231
- 3014273557
- 3043237012
- 3004577612
- 2648727
- 3015058854
- 1000292485
- 3016440583
- 1221084
- 1423561
- 3011669224
- 3036714922
- 3004727093
- 3009235796
- 3017171467
- 2437956
- 3005150489
- 1931307
- 3009265647
- 3008771621
- 3039359026
- 3009407891
- 3007120364
- 3003123807
- 3032618
- 3004194020
- 3007309323
- 3014810929
- 2429947
- 2937137
- 3004111085
- 3007289408
- 3010461764
- 3009596133
- 3005720080
- 3011134213
- 3007499787
- 9615543
- 3030410174
- 3001657382
- 3031658417
- 3013538349
Source Documents#
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#
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