MyoSleeve

Basic Information

• Brand Name: MyoSleeve
• Primary DI: 07290020483072
• Version / Model: 1.0
• Catalog Number: HL-XL-Lt-St
• Company Name: ELASTIMED LTD
• Labeler DUNS: 600461703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-01
• Public Version: 1
• Public Version Date: 2026-01-09
• Public Version Status: New
• Public Device Record Key: b103b1b5-5e70-4466-a92a-aecfc35d35b3

Device Description

MyoSleeve Half leg, X-Large, Left, Short

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
Package	17290020483079	GS1	Carton	1	In Commercial Distribution
Primary	07290020483072	GS1
Package	27290020483076	GS1	Carton	2	In Commercial Distribution
Package	47290020483070	GS1	Carton	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232300	000