Ballancer 505 1201-AC USA

FDA UDI

Class II (US FDA UDI)

by MEGO afek Agricultural Cooperative Society Ltd

Identity

Trade Name: Ballancer 505 1201-AC USA FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: Ballancer® 505 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 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: 1201AC FDA UDI
Description: Ballancer® 505 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 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

Catalog Number: L10505CBA FDA UDI
Primary DI / UDI-DI: 07290105871213 FDA UDI
510(k) Number: K150269 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 505 1201-AC USA by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Sequential venous compression system inflator.

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Medline — MEDLINE INDUSTRIES, INC. · Class II
Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
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TRIPLE PLAY — Compression Solutions, LLC · Class II

Cleared under the same submission

K150269 also covers:

Ballancer 505 V2 1201-AC — MEGO afek Agricultural Cooperative Society Ltd

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 edcb9848-91a6-4e05-9acb-15c3ebe1d6f7 36 fields · synced May 31, 2026