FDA Registration
Active
🇨🇳 China
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
Reg #: 3012521614
·
FEI: 3012521614
·
Expires 2026
Products
4
Proprietary Names
24
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
- Registration Number
- 3012521614
- FEI Number
- 3012521614
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.196 Industry Road, Hengdian Movie Zone
- City
- Dongyang Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220747
Owner / Operator
- Firm Name
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- Operator Number
- 10051686
- Address
- No.196 Industry Road,, Hengdian Movie Zone
- City
- Dongyang
- State
- Zhejiang
- Postal Code
- 322118
- Country
- CN
- Correspondent
- Yolanda Ge
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2022-05-24 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2022-04-19 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2020-08-20 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2023-05-12 |
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
Mobility Scooter, Model W3431
Mobility Scooter, Models W3431Q, W3431R
Mobility Scooter, Model W3468A
Mobility Scooter, Model W3431D
Power Wheelchair, Model N5909
Mobility Scooter, Model N3473
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)