Protekt O2

FDA UDI

Class I (US FDA UDI)

by Proactive Medical Products

Identity

Trade Name: Protekt O2 FDA UDI
Generic Name: Air-filled chair cushion FDA UDI
Device Name: PROTEKT O2 CUSHION DRY FLOTATION SEATING 18" HIGH PROFILE FDA UDI
Model / Reference: 78005 FDA UDI
Description: PROTEKT O2 CUSHION DRY FLOTATION SEATING 18" HIGH PROFILE FDA UDI

Identifiers

Catalog Number: 78005 FDA UDI
Primary DI / UDI-DI: 05060488570285 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 4 Inch FDA UDI
Length — 16 Inch FDA UDI
Width — 18 Inch FDA UDI

Category: Air-filled chair cushion

Protekt O2 by Proactive Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-filled chair cushion.

ROHO LOW PROFILE Single Compartment Cushion — Roho, Inc. · Class I
Varilite — Cascade Designs, Inc. · Class I
Varilite — Cascade Designs, Inc. · Class I
Star — KI MOBILITY, LLC · Class I
Star — KI MOBILITY, LLC · Class I
ROHO QUADTRO SELECT HIGH PROFILE Cushion — Roho, Inc. · Class I
WAFFLE — EHOB, INC. · Class I
ROHO MID PROFILE Single Compartment Cushion — Roho, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Proactive Medical Products

Sources (1)

FDA UDI 5b59caac-56df-41d8-9da0-a11c21a03a3f 36 fields · synced Jun 1, 2026