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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications

CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions

SubmissionSupplement
K232640000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232640000Venowave VW5Thermabright2024-06-25JOW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00627843553595PackageGS120In Commercial Distribution
00683601000053PreviousGS10
00627843553601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843553595006278435535956278435535950627843553595
00683601000053006836010000536836010000530683601000053
00627843553601006278435536016278435536010627843553601

GMDN Terms

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

TypeValueUnit
Height48Millimeter
Length190Millimeter
Weight270Gram
Width100Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
8442746837info@thermabright.com

Regulatory Flags

DUNS number
200775422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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