FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798128672911
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1203-306 U S
Device description
CORRECTOR DE POSTURA ELASTICO- U S
Published
2024-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPTOrthosis, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798128672911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798128672911077981286729117798128672911

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle orthosisA prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It is formed as a figure-of-eight harness that descends from the shoulders, passes under each arm and crosses over the back. It has broad, padded straps and may have extra padding inserted at the back. This device may also be used to improve the patient's posture. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
971365986
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798128671303PROFIT1101-EM1 U S2024-02-14
07798128671310PROFIT1101-EM1 U M2024-02-14
07798128671327PROFIT1101-EM1 U L2024-02-14
07798094541310WELLBRACE1101-6000 U U2024-01-05
07798094547930WELLBRACE1102-6020 U U2024-01-05
07798128673499WELLBRACE1101-M8 U S2024-01-05
07798128673505WELLBRACE1101-M8 U M2024-01-05
07798128673512WELLBRACE1101-M8 U L2024-01-05
07798094549392PROFIT1601-1313 U U2024-01-04
07798094549408PROFIT1601-1325 U U2024-01-04
07798094549415PROFIT1601-2425 U U2024-01-04
07798094540023WELLBRACE1601-AR U U2024-01-08
07798094540627WELLBRACE1204-610 U S2024-01-05
07798094540634WELLBRACE1204-610 U M2024-01-05
07798094540641WELLBRACE1204-610 U L2024-01-05
07798094540658WELLBRACE1204-610 U XL2024-01-05
07798094540665WELLBRACE1204-610 U 2XL2024-01-05
07798094540672WELLBRACE1204-611 U S2024-01-05
07798094540689WELLBRACE1204-611 U M2024-01-05
07798094540696WELLBRACE1204-611 U L2024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178888092CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888665CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888894CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889075CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889174CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889259CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889266CoreTechVIVE HEALTH LLCIPT2026-05-05
00850071315264TrendOrthofix US LLCIPT2026-04-25
00850071315240TrendOrthofix US LLCIPT2026-04-14
00850071315257TrendOrthofix US LLCIPT2026-04-14
00850071315271TrendOrthofix US LLCIPT2026-04-14
00810113682716Tailback2-56Manamed, Inc.IPT2025-09-19
00810113682723Tailback2-64Manamed, Inc.IPT2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IPT2025-08-05
04823097722114"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722121"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722138"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722145"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722152"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722169"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722176"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17
04823097722183"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722190"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722206"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722213"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722220"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722237"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722244"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17