Ballancer Gold (US)

Basic Information

• Brand Name: Ballancer Gold (US)
• Primary DI: 07290105879165
• Version / Model: 1212
• Company Name: MEGO afek Agricultural Cooperative Society Ltd
• Labeler DUNS: 514658082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-24
• Public Version: 1
• Public Version Date: 2020-01-01
• Public Version Status: New
• Public Device Record Key: 95ffa51f-6661-413a-b527-c9fd4e5b9c12

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44785	Sequential venous compression system pump	An electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290105879165	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190015	000