FDA.reportPublic FDA data

MyoSleeve

Primary DI
17290020483024
Brand
MyoSleeve
Company
ELASTIMED LTD
Model
1.0
Catalog number
HL-M-Rt-St
Device description
MyoSleeve Half leg, Medium, Right, Short
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
17290020483024PackageGS11In Commercial Distribution
27290020483021PackageGS12In Commercial Distribution
47290020483025PackageGS14In Commercial Distribution
07290020483027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729002048302417290020483024
2729002048302127290020483021
4729002048302547290020483025
07290020483027072900204830277290020483027

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 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
07290020483072MyoSleeve1.0HL-XL-Lt-St2026-01-01
17290020483017MyoSleeve1.0HL-S-Lt-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
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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