Data / Medical devices / China / Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.: FDA-registered device maker in Dongyang Zhejiang, China, 20 510(k) clearances
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. is registered with the FDA (registration 3012521614) in Dongyang Zhejiang, China. It lists 4 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012521614
- Address
- No.196 Industry Road Hengdian Movie Zone, Dongyang Zhejiang, China, 322118
- Owner or operator
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd. (10051686)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 20, 2020
- Registered through
- 2026
- Brand names listed
- Back Upholstery, Base Cushion, Seat Pan, Armrests assembly L , Armrests assembly R, Armpads L, Armpads R, Drive Wheels,, DGN2305798 INNER LINER, RIGHT, DGN2504973 REAR DOOR WITH INSERTS, DGN2504974 REAR DOOR ASSEMBLY, DGN2504975 REAR DOOR INSERT FOR CAMERA INSERTS, DGN2504976 CAMERA PLUG WITH INSERT, DGN2508452 MAIN CARRIER SHROUD WITH INSERTS, DGN2508456 MAIN CARRIER SHROUD WITH CATCHES, Drive Wheel Mounting Kit, Caster Wheels, Caster W/ Fork & Wheel, Caster Arm W/ Fork & Wheel, Caster Arm W/ Fork & Wheel,, HDW131319 SCREW, SOCKET CUP POINT SET, M8X1.25 X 12, ISO 4029, 45H, BZ,PVTP;MEC2401170 TOWER,250MM SPACING, BASIC STATIC, HDW1904342 SCREW, SOCKET HEAD, M4X0.7 X 10, ISO 4762, CL 10.9, BZ, PVTP;MEC2401169 TOWER, 315MM SPACING,PED BASIC STATIC, HDW2102618 WASHER, 8.5 ID X 22 OD X 3.6 THK, NYLON, BLACK, DWG 2102618;MEC2401264 TALL TOWER,250MM SPACING, BASIC STATIC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Wheelchair | KNN | 1 | Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2026 | K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| June 18, 2026 | K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| June 5, 2026 | K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| April 20, 2026 | K253806 | Power Wheelchair (N5919 series) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| November 18, 2024 | K242471 | Power Wheelchair (W5538) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| October 11, 2024 | K242387 | Mobility Scooter (N3473) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| September 10, 2024 | K240990 | Mobility Scooter | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| June 5, 2024 | K240008 | Mobility Scooter (W3331) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| May 2, 2024 | K240012 | Mobility Scooter (W3431) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| December 13, 2023 | K230964 | Power Wheelchair (N5909) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| November 9, 2023 | K231508 | Power Wheelchair, W5521 | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| July 14, 2023 | K231428 | Mobility Scooter (Models: W3431D) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| February 28, 2023 | K222507 | Mobility Scooter (Models: W3431Q, W3431R) | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| October 17, 2022 | K222495 | Mobility Scooter, Model: W3331F | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| July 1, 2022 | K221026 | Power Wheelchair | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| May 12, 2022 | K220747 | Power Wheelchair (N5515B) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| May 12, 2022 | K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| March 24, 2022 | K220207 | Mobility Scooter, Model W3468 | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| March 24, 2022 | K220206 | Mobility Scooter | INI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| July 23, 2015 | K143383 | Q6 Edge EM | ITI | Substantially Equivalent | Pride Mobility Product Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
- All makers of Components, Wheelchair
Updated August 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.