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Innuovo

FDA UDI

Class II (US FDA UDI)

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd

Identity

Trade Name
Innuovo FDA UDI
Generic Name
Wheelchair, power-assisted, attendant/occupant-controlled, collapsible FDA UDI
Model / Reference
N5513A-091 FDA UDI

Identifiers

Primary DI / UDI-DI
06970765970914 FDA UDI
510(k) Number
K070501 FDA UDI
FDA Product Code
ITI FDA UDI
GMDN Term
Wheelchair, power-assisted, attendant/occupant-controlled, collapsible FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wheelchair, power-assisted, attendant/occupant-controlled, collapsible

Innuovo by Zhejiang Innuovo Rehabilitation Devices Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair, power-assisted, attendant/occupant-controlled, collapsible.

Cleared under the same submission

K070501 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd

Sources (1)

  • FDA UDI 62242a4e-6e72-4a9f-b032-78a633dc5e6d 33 fields · synced May 30, 2026