FDA.reportPublic FDA data

Ballancer Pro Jacket

Primary DI
07290105873996
Brand
Ballancer Pro Jacket
Company
MEGO afek Agricultural Cooperative Society Ltd
Model
Bal Jacket
Catalog number
L4MJ4120
Device description
The Ballancer Pro Jacket inflatable garment is 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.
Published
2019-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013331000LYMPHA PRESS PLUS DEVICEMego Afek2001-11-30JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105873996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105873996072901058739967290105873996

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. 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. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
7327929677info@lympha-press.com

Regulatory Flags#

DUNS number
514658082
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290105871213Ballancer 505 1201-AC USA1201ACL10505CBA2019-12-24
07290105871480Nano Press 760A (US)760AL10007A2-US2019-12-24
07290105871497RP Lite 760R760RL10007AR2019-12-24
07290105878670Ballancer 505 V2 1201-AC1201ACL10004C6-US2019-12-24
07290105878939Optimal 1201AD Optimized for Pod1201ADL10003C7P2019-12-24
07290105878946Lympha Press Optimal 1201AD1201ADL10003C7U2019-12-24
07290105879042Phlebo Press DVT 760D (US)760DL10007D42019-12-24
07290105879110Lympha Press Optimal Plus(US) BT912L10008C2-US2019-12-24
07290105879165Ballancer Gold (US)12122019-12-24
07290105879325RPX 737R Device 2020737RL10005H2R-US2019-12-24
07290105879332PCD-51 731A (US) - White731AL10015G12019-12-24
07290105879431PCD-52™ 737A (US) White737AL10015H12019-12-24
07290105870155201Max Calibrated device201MaxL10000632019-12-24
07290105875402Calf&Foot L NRC-DVTDVT C&F L SPUL4ZD23302023-02-12
07290105872685#4 Adult Boot XL (4 cells)4 Boot XLL41204402019-12-24
07290105872692Adult Boot # 1A RC-FLSBoot 1AL41211102019-12-24
07290105872708Adult boot No. 2A RC-FLSBoot 2AL41212102019-12-24
07290105872791FL sleeve 2-75 RC-FLSFL 2-75L41320752019-12-24
07290105872807FL sleeve 2-85 RC-FLSFL 2-85L41320852019-12-24
07290105872852FL sleeve 3-85 RC-FLSFL 3-85L41330852019-12-24

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