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Fuze Manual Tilt Wheelchair

FDA UDI

Class I (US FDA UDI)

by PDG Product Design Group Inc

Identity

Trade Name
Fuze Manual Tilt Wheelchair FDA UDI
Generic Name
Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible FDA UDI
Model / Reference
FUZE JR FDA UDI

Identifiers

Catalog Number
5517 FDA UDI
Primary DI / UDI-DI
B829171 FDA UDI
510(k) Number
K063736 FDA UDI
FDA Product Code
IOR FDA UDI
GMDN Term
Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3850 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible

Fuze Manual Tilt Wheelchair by PDG Product Design Group Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible.

Cleared under the same submission

K063736 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PDG Product Design Group Inc

Sources (1)

  • FDA UDI 1bf5d01e-f18e-426c-9705-464703480f05 35 fields · synced May 31, 2026