510(k) K011744
- Device
- HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
- Applicant
- TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
- 510(k) number
- K011744
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-24
- Date received
- 2001-06-05
- Regulation
- 890.3860
- Classification name
- Wheelchair, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUAN C RIVERA
- Address
- 6140 Mild Metro Dr. Suite #6 Fort Myers FL US 33912 33912
FDA Registration Numbers#
- 3007675960
- 3001185828
- 3027135885
- 3003650116
- 9616881
- 3004730072
- 3011749761
- 3049848766
- 3021071770
- 3008370857
- 3011969521
- 3003857817
- 3022982004
- 1058069
- 3043711862
- 3048285037
- 3043088974
- 8043717
- 3005260401
- 3043165991
- 3015992762
- 3026585646
- 9616873
- 3010547267
- 3007608806
- 3032587493
- 3003636180
- 1221084
- 3011962812
- 3008812160
- 3008841035
- 3014522447
- 3012521614
- 3008466210
- 3012538618
- 3012274425
- 3044470904
- 3014266593
- 3009265647
- 3004142507
- 3004594214
- 3004443928
- 3032014158
- 3014273557
- 3011191255
- 3016969129
- 3042501731
- 3038189190
- 2937137
- 3008597995
- 9615350
- 3034732597
- 3033848621
- 2027797
- 3033796886
- 3021374638
- 3035853002
- 3030927010
- 2531465
- 3013025777
- 3039359026
- 3030822491
- 3007963811
- 3010461764
- 3020640553
- 9618009
- 3003882673
- 3008717361
- 3014983822
- 3006160539
- 3017959212
- 3004024088
- 3031588965
- 3045076265
- 3014471045
- 3013934051
- 3036988603
- 3016195086
- 3014653196
- 3027344674
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261079 | Power Wheelchair (DC12) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-06 |
| K261200 | Power Wheelchair (D60) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-06 |
| K262241 | Electric Wheelchair (0080) | Xuzhou Heabens Medical Technology Co., Ltd. | 2026-09-29 |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | 2026-09-23 |
| K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | 2026-09-16 |
| K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | 2026-09-08 |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | 2026-09-08 |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | 2026-08-21 |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 |
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