Ballancer Gold (US)

FDA UDI

Class II (US FDA UDI)

by MEGO afek Agricultural Cooperative Society Ltd

Identity

Trade Name: Ballancer Gold (US) FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: Ballancer® Gold is a massage system intended for use by people in good health. As noted above, Ballancer® Gold simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion. FDA UDI
Model / Reference: 1212 FDA UDI
Description: Ballancer® Gold is a massage system intended for use by people in good health. As noted above, Ballancer® Gold simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290105879165 FDA UDI
510(k) Number: K190015 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

Ballancer Gold (US) by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: MEGO afek Agricultural Cooperative Society Ltd

Sources (1)

FDA UDI 95ffa51f-6661-413a-b527-c9fd4e5b9c12 35 fields · synced Jun 8, 2026