ManaMed

FDA UDI

Class I (US FDA UDI)

by Manamed Llc

Identity

Trade Name: ManaMed FDA UDI
Generic Name: Compression/pressure tubular garment FDA UDI
Device Name: ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This hip brace also includes two high quality ice packs. Quick fitting Cold compression Range of motion hinge Universally sized FDA UDI
Model / Reference: ManaEZ Hip Ice (Brace) FDA UDI
Description: ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This hip brace also includes two high quality ice packs. Quick fitting Cold compression Range of motion hinge Universally sized FDA UDI

Identifiers

Catalog Number: EZHIP01B FDA UDI
Primary DI / UDI-DI: 00810113682419 FDA UDI
FDA Product Code: ITS FDA UDI
IRP FDA UDI
GMDN Term: Compression/pressure tubular garment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 FDA UDI
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Compression/pressure tubular garment Hip orthosis

ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hip orthosis.

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MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
Vive — VIVE HEALTH LLC · Class I
Vive — VIVE HEALTH LLC · Class I
MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
BMI — Blake Manufacturing, 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: Manamed Llc

Sources (1)

FDA UDI 9692449b-e798-428b-b428-947ca701cceb 35 fields · synced Jun 8, 2026