FDA.reportPublic FDA data

Compressible Limb Therapy System

Primary DI
18809315678985
Brand
Compressible Limb Therapy System
Company
DAESUNG MAREF CO.,LTD.
Model
MK300L
Device description
Compressible Limb Therapy System pump with 1arm sleeve, 2extension zipper and 4single hoses.
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K112441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112441000COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMDaesung Maref Co., Ltd.2012-01-17IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809315678985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880931567898518809315678985

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688817949
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809802648494DVT-SERIESDS0312026-02-09
08809802648500DVT-SERIESDS0332026-02-09
18809802648491DVT-SERIESDS0312026-02-09
18809802648507DVT-SERIESDS0332026-02-09
08809802645301SP-1000SP10100-LL2025-12-19
08809802645318SP-1000SP10100-LX2025-12-19
08809802645325SP-1000SP10100-LZ2025-12-19
08809802645462SP-2000SP20100-LL2025-12-19
08809802645479SP-2000SP20100-LX2025-12-19
08809802645486SP-2000SP20100-LZ2025-12-19
08809802646131LX9maxLX9M100-LL2025-12-19
08809802646148LX9maxLX9M100-LX2025-12-19
08809802646155LX9maxLX9M100-LZ2025-12-19
08809802646810DVT-2600DVT3120-DT2025-12-19
08809802646858DVT-4000SDVT4100-DT2025-12-19
08809802645295SP-1000SP101002025-12-19
18809802645308SP-1000SP10100-LL2025-12-19
18809802645315SP-1000SP10100-LX2025-12-19
18809802645322SP-1000SP10100-LZ2025-12-19
08809802645332SP-1000SP10100-RL2025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.IRP2026-07-31