FDA.reportPublic FDA data

Shoulder Brace

Primary DI
06974500613593
Brand
Shoulder Brace
Company
GCMEDICA ENTERPRISE LTD.(WUXI)
Model
JP07A01
Device description
Resuable and Adjustable Shoulder BraceMaterials: Nylon,NeopreneSize: One Size,fits left and right shoulder
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IOYSupport, Arm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974500613590PackageGS16In Commercial Distribution
06974500613593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697450061359016974500613590
06974500613593069745006135936974500613593

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.

Regulatory Flags#

DUNS number
560122957
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974500612718Rigid Uterine Aspiration CuretteGC7049A07AU012026-05-18
06974500612725Rigid Uterine Aspiration CuretteGC7049A08AU012026-05-18
06974500612732Rigid Uterine Aspiration CuretteGC7049A09AU012026-05-18
06974500612749Rigid Uterine Aspiration CuretteGC7049A10AU012026-05-18
06974500612756Rigid Uterine Aspiration CuretteGC7049A11AU012026-05-18
06974500612763Rigid Uterine Aspiration CuretteGC7049A12AU012026-05-18
06974500612770Rigid Uterine Aspiration CuretteGC7049A14AU012026-05-18
06974500612787Rigid Uterine Aspiration CuretteGC7049A16AU012026-05-18
06974500612794Rigid Uterine Aspiration CuretteGC7049D14AU012026-05-18
06974500612824Rigid Uterine Aspiration CuretteGC7049B07BU012026-05-18
06974500612831Rigid Uterine Aspiration CuretteGC7049B08BU012026-05-18
06974500612848Rigid Uterine Aspiration CuretteGC7049B09BU012026-05-18
06974500612855Rigid Uterine Aspiration CuretteGC7049B10BU012026-05-18
06974500612862Rigid Uterine Aspiration CuretteGC7049B11BU012026-05-18
06974500612879Rigid Uterine Aspiration CuretteGC7049B12BU012026-05-18
06974500612886Rigid Uterine Aspiration CuretteGC7049B14BU012026-05-18
06974500612893Rigid Uterine Aspiration CuretteGC7049B16BU012026-05-18
06974500612909Rigid Uterine Aspiration CuretteGC7049E14BU012026-05-18
06974500613333Flexible Uterine Aspiration CuretteGC7049C04AU012026-05-18
06974500613340Flexible Uterine Aspiration CuretteGC7049C05AU012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
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