510(k) K915108
- Device
- FOLDING WHEELCHAIR
- Applicant
- GUARDIAN PRODUCTS CO., INC.
- 510(k) number
- K915108
- Product code
- IOR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-13
- Date received
- 1991-11-13
- Regulation
- 890.3850
- Classification name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALVIN R.BALL
- Address
- 12222 Sherman Way North Hollywood CA US 91605 91605
FDA Registration Numbers#
- 3030452839
- 3008771621
- 3044085583
- 3019677893
- 3023189540
- 3009302777
- 3009282549
- 3007912863
- 2183191
- 3016601021
- 3043748437
- 3016678950
- 3005720080
- 3006799874
- 1000292485
- 3004473024
- 9616881
- 3013538349
- 3007675960
- 3043749706
- 3011475060
- 3001657382
- 3004149089
- 3016969129
- 3021027216
- 3014421917
- 3038189860
- 9618009
- 3010273872
- 3007608806
- 1422443
- 3015220328
- 3039359026
- 1423561
- 3006160539
- 3014293077
- 3012316249
- 3009327812
- 3009235818
- 3004141004
- 3004034546
- 3032597250
- 3009265647
- 3021327432
- 3005260401
- 2531465
- 3015967131
- 3005858417
- 3011714211
- 2648727
- 3043460907
- 3019505063
- 3011134213
- 3005150489
- 2937137
- 3003823002
- 3011191255
- 3011687503
- 1000252066
- 3003832369
- 3003162820
- 3015772781
- 3005905321
- 3010394125
- 3007289408
- 1931307
- 3007309323
- 9615543
- 2437956
- 3010461764
- 9616091
- 2429947
- 3003781173
- 3017171467
- 3009235796
- 3011781238
- 3004496806
- 3043237012
- 3008723825
- 3004194020
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
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