FDA.reportPublic FDA data

SACS PRO

Primary DI
07290020483089
Brand
SACS PRO
Company
ELASTIMED LTD
Model
1.0
Catalog number
Pro-HL
Device description
SACS PRO
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243177000SACS PROElastimed , Ltd.2024-12-23IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290020483086PackageGS11In Commercial Distribution
07290020483089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729002048308617290020483086
07290020483089072900204830897290020483089

GMDN Terms#

Term, Definition table
TermDefinition
Wearable electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.

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
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
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

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08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
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