FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798094540870
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1207-635 U S
Device description
FAJA SACROLUMBAR SUPER COMODA- U S
Published
2024-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPYOrthosis, Lumbo-Sacral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798094540870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798094540870077980945408707798094540870

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
00854682001967ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001974ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001981ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
06974500613432Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
16974500613439Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
00810113683072Extension Panel - Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-11-25
00810113683492ManaMomma Maternity Back BraceManamed, Inc.IPY2025-10-03
00810113683508ManaMomma Maternity Back Brace, Custom Label Manamed, Inc.IPY2025-10-03
00810113683546Tailback2-50 CureTechManamed, Inc.IPY2025-10-03
00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
00810113682884Halfback2-50Manamed, Inc.IPY2025-09-19
00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
05391512281229ACTIVDAYINDACO SRLIPY2024-02-09
05391512281236ACTIVDAYINDACO SRLIPY2024-02-09
05391512281250ACTIVDAYINDACO SRLIPY2024-02-09
05391512281267ACTIVDAYINDACO SRLIPY2024-02-09
05391512281755ACTIVDAYINDACO SRLIPY2024-02-09
05391512281762ACTIVDAYINDACO SRLIPY2024-02-09
05391512281779ACTIVDAYINDACO SRLIPY2024-02-09
05391512281786ACTIVDAYINDACO SRLIPY2024-02-09
05391512281793ACTIVDAYINDACO SRLIPY2024-02-09
05391512281809ACTIVDAYINDACO SRLIPY2024-02-09
05391512281816ACTIVDAYINDACO SRLIPY2024-02-09
05391512286026ACTIVDAYINDACO SRLIPY2024-02-09
05391512286033ACTIVDAYINDACO SRLIPY2024-02-09
05391512286057ACTIVDAYINDACO SRLIPY2024-02-09
05391512286064ACTIVDAYINDACO SRLIPY2024-02-09
05391512286095ACTIVDAYINDACO SRLIPY2024-02-09
05391512286101ACTIVDAYINDACO SRLIPY2024-02-09
05391512286118ACTIVDAYINDACO SRLIPY2024-02-09