Venowave VW5

Primary DI
00627843553601
Brand
Venowave VW5
Company
Therma Bright Inc
Model
VW5-6
Device description
The Venowave VW5 series comprises compact, battery-operated non-pneumatic, non-sequential, peristaltic wave compression pumps designed to generate wave-form motion. When securely fastened below the knee on the calf, these pumps create compression, leading to an increased upward volumetric displacement of venous and lymph fluid. The device is used for Management of the symptoms of post thrombolytic syndrome (PTS), Prevention of deep vein thrombosis (DVT), Prevention of primary thrombosis, Treatment of lymphedema, Diminishing post-operative pain and swelling, Treatment of leg swelling due to vascular insufficiency, Treatment of varicose veins Treatment of chronic venous insufficiency.
Published
2024-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K232640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232640000Venowave VW5Thermabright2024-06-25JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627843553595PackageGS120In Commercial Distribution
00683601000053PreviousGS10
00627843553601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843553595006278435535956278435535950627843553595
00683601000053006836010000536836010000530683601000053
00627843553601006278435536016278435536010627843553601

GMDN Terms#

Term, Definition table
TermDefinition
Wearable sequential venous compression systemA noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height48Millimeter
Length190Millimeter
Weight270Gram
Width100Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8442746837info@thermabright.com

Regulatory Flags#

DUNS number
200775422
Device count
1
Lot or batch
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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