Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012521614

FEI Number

3012521614

Entity Name

ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.

City/State/Country

Dongyang Zhejiang, CN

Establishment Address

No.196 Industry Road, Hengdian Movie Zone, Dongyang Zhejiang 322118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Innuovo Rehabilitation Devices Co., Ltd. (Owner Number: 10051686)

Owner / Operator Contact Address

No.196 Industry Road,, Hengdian Movie Zone, Dongyang, CN-ZJ 322118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242471

PMA Number

N/A

All Registered Proprietary Names

Power Wheelchair, Models N5515B,W5915B,W5915D Mobility Scooter, Model W3468 Mobility Scooter, Model W3901 Rollator Power Wheelchair, Model W 5907(Q50 R Carbon) Power Wheelchair, Model W5905 Mobility Scooter, Model W3331 QUANTUM BARIATRIC 451 Power Wheelchair, Model W5521 Mobility Scooter, Model W3331F Drive Wheel Mounting Kit, Caster Wheels, Caster W/ Fork & Wheel, Caster Arm W/ Fork & Wheel, Caster Arm W/ Fork & Wheel, Joystick Mounting Bracket, Power Module M7084, Battery Charger W/ Cord 2A, Footplatform, Frame Strap, Storage Bag, Motors L&R, Motor Mounting Kit, Anti Tip Wheels, Anti Tip Arm W/ Wheel, Main Frame Rear Latch, Joystick, JAZZY CARBON, SEAT FRAME, WHITE, JAZZY CARBON Back Upholstery, Base Cushion, Seat Pan, Armrests assembly L , Armrests assembly R, Armpads L, Armpads R, Drive Wheels, Lap Belt, Main Frame, Battery Box W/ Battery 24V12Ah, Armrest Knob, LOWER MAIN FRAME, WHITE, LOWER FRAME, WHITE, Powered Wheelchair 3421, W5213 Power Wheelchair, Model W5538

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-05-24
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2022-04-19
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2024-09-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-04-22
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2020-08-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-05-24
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-07-11
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2024-06-28
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-08-16
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2023-11-20
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2022-12-12
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2023-05-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2016-04-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-12-15

Official Correspondent

Yolanda Ge

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012521614. Last updated year: 2026. Please use registration number 3012521614 when referencing this establishment in official correspondence.