FDA.reportPublic FDA data

MyoSleeve

Primary DI
07290020483072
Brand
MyoSleeve
Company
ELASTIMED LTD
Model
1.0
Catalog number
HL-XL-Lt-St
Device description
MyoSleeveHalf leg, X-Large, Left, Short
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K232300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232300000ElastiMed SACSElastimed , Ltd.2023-12-22JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290020483079PackageGS11In Commercial Distribution
27290020483076PackageGS12In Commercial Distribution
47290020483070PackageGS14In Commercial Distribution
07290020483072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729002048307917290020483079
2729002048307627290020483076
4729002048307047290020483070
07290020483072072900204830727290020483072

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.

Contacts#

Phone, Email table
PhoneEmail
+1(844) 679-9100support@elastimed.com

Regulatory Flags#

DUNS number
600461703
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290020483089SACS PRO1.0Pro-HL2026-05-06
07290020483010MyoSleeve1.0HL-S-Lt-St2026-01-01
07290020483027MyoSleeve1.0HL-M-Rt-St2026-01-01
07290020483034MyoSleeve1.0HL-M-Lt-St2026-01-01
07290020483041MyoSleeve1.0HL-L-Rt-St2026-01-01
07290020483058MyoSleeve1.0HL-L-Lt-St2026-01-01
07290020483065MyoSleeve1.0HL-XL-Rt-St2026-01-01
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
07290020483003MyoSleeve1.0HL-S-Rt-St2025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
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96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18