Mueller Sports Medicine

FDA UDI

Class II (US FDA UDI)

by Mueller Sports Medicine, Inc.

Identity

Trade Name: Mueller Sports Medicine FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: M4 Revive Console FDA UDI
Model / Reference: M4 FDA UDI
Description: M4 Revive Console FDA UDI

Identifiers

Catalog Number: M4 FDA UDI
Primary DI / UDI-DI: 00074676006802 FDA UDI
510(k) Number: K190493 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Sequential venous compression system inflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sequential venous compression system inflator

Mueller Sports Medicine by Mueller Sports Medicine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sequential venous compression system inflator.

AIROS — AIROS MEDICAL INC · Class II
LF900 — DAESUNG MAREF CO., LTD. · Class II
Therabody — Therabody, Inc. · Class II
The Venous Assist System — DAESUNG MAREF CO., LTD. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 — Maxstar Industrial Co., Ltd. · Class II
TRIPLE PLAY — Compression Solutions, LLC · Class II

Cleared under the same submission

K190493 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Mueller Sports Medicine, Inc.

Sources (1)

FDA UDI 3b3e93c6-33fa-4566-ab78-f10cfc37be15 37 fields · synced Jun 9, 2026