Ibramed

FDA UDI

Class II (US FDA UDI)

by Ibramed Industria Brasileira de Equipamentos Medicos Eir

Identity

Trade Name: Ibramed FDA UDI
Generic Name: Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL FDA UDI
Model / Reference: NEURODYN MULTIWAVE FDA UDI
Description: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL FDA UDI

Identifiers

Primary DI / UDI-DI: 07898961579016 FDA UDI
510(k) Number: K131629 FDA UDI
FDA Product Code: IPF FDA UDI
GZJ FDA UDI
GZI FDA UDI
LIH FDA UDI
GMDN Term: Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
882.5890 FDA UDI
882.5810 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

Ibramed by Ibramed Industria Brasileira de Equipamentos Medicos Eir — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131629 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: Ibramed Industria Brasileira de Equipamentos Medicos Eir

Sources (1)

FDA UDI 76b46128-577e-4381-8ec0-88d55fea96ad 35 fields · synced Jun 8, 2026