FDA.report

MyoSleeve

Primary DI
07290020483003
Brand
MyoSleeve
Company
ELASTIMED LTD
Model
1.0
Catalog number
HL-S-Rt-St
Device description
MyoSleeve Half leg, Small, Right, Short
Published
2025-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K232300000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232300000ElastiMed SACSElastimed , Ltd.2023-12-22JOW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17290020483000PackageGS11In Commercial Distribution
27290020483007PackageGS12In Commercial Distribution
47290020483001PackageGS14In Commercial Distribution
07290020483003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1729002048300017290020483000
2729002048300727290020483007
4729002048300147290020483001
07290020483003072900204830037290020483003

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844) 679-9100support@elastimed.com

Regulatory Flags

DUNS number
600461703
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
17290020483017MyoSleeve1.0HL-S-Lt-St2026-01-01
17290020483024MyoSleeve1.0HL-M-Rt-St2026-01-01
17290020483031MyoSleeve1.0HL-M-Lt-St2026-01-01
17290020483048MyoSleeve1.0HL-L-Rt-St2026-01-01
17290020483055MyoSleeve1.0HL-L-Lt-St2026-01-01
17290020483062MyoSleeve1.0HL-XL-Rt-St2026-01-01
17290020483079MyoSleeve1.0HL-XL-Lt-St2026-01-01

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