Venowave VW5

Basic Information

• Brand Name: Venowave VW5
• Primary DI: 00627843553601
• Version / Model: VW5-6
• Company Name: Therma Bright Inc
• Labeler DUNS: 200775422
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-17
• Public Version: 2
• Public Version Date: 2026-04-27
• Public Version Status: Update
• Public Device Record Key: 3e9ca9e9-2fe2-45d5-aa79-c2a51f9e8522

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Manufacturing Date: No
• 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
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63558	Wearable sequential venous compression system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627843553601	GS1
Package	00627843553595	GS1	Box	20	In Commercial Distribution
Previous	00683601000053	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	270	Gram
Length	190	Millimeter
Width	100	Millimeter
Height	48	Millimeter