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ROHO Single Compartment Cushion

FDA UDI

Class I (US FDA UDI)

by Roho, Inc.

Identity

Trade Name
ROHO Single Compartment Cushion FDA UDI
Generic Name
Air-filled chair cushion FDA UDI
Device Name
Modified configuration of a ROHO Single Compartment Cushion. It may be any size and include high, mid, or low profile cells. FDA UDI
Model / Reference
1RMODIFIED FDA UDI
Description
Modified configuration of a ROHO Single Compartment Cushion. It may be any size and include high, mid, or low profile cells. FDA UDI

Identifiers

Primary DI / UDI-DI
00613732053352 FDA UDI
FDA Product Code
KIC FDA UDI
GMDN Term
Air-filled chair cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3175 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Air-filled chair cushion

ROHO Single Compartment Cushion by Roho, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-filled chair cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roho, Inc.

Sources (1)

  • FDA UDI 883b2dfe-8fad-4839-91e4-fac853817211 33 fields · synced May 30, 2026