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Setmark Incorporated

FDA UDI

Class I (US FDA UDI)

by Setmark Inc.

Identity

Trade Name
Setmark Incorporated FDA UDI
Generic Name
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
Device Name
Wheelchair, Alum. 22' seat width, 16' seat depth, 350lb cap., flip up arms, Dark Blue Vinyl, S/A footrest FDA UDI
Model / Reference
NF-102 FDA UDI
Description
Wheelchair, Alum. 22' seat width, 16' seat depth, 350lb cap., flip up arms, Dark Blue Vinyl, S/A footrest FDA UDI

Identifiers

Primary DI / UDI-DI
00854204008405 FDA UDI
510(k) Number
K973418 FDA UDI
FDA Product Code
IOR FDA UDI
GMDN Term
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Setmark Incorporated by Setmark Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible.

Cleared under the same submission

K973418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Setmark Inc.

Sources (1)

  • FDA UDI 8390e6e2-bebe-4f29-ae31-dd8864f38fb3 34 fields · synced Jun 8, 2026