FDA.reportPublic FDA data

Pro-Fit Back Brace

Primary DI
00859718007265
Brand
Pro-Fit Back Brace
Company
Emsi
Model
FLEBB0003 - Back
Published
2023-03-21
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
00859718007265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859718007265008597180072658597180072650859718007265

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932471881
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859718007296Hypoallergenic Electrode 2x2 4pkBF50502025-12-16
00085971800729Hypoallergenic Electrode 2x2 4pkBF50502024-08-18
00858688006261TENS 3000EMS-DT30022016-09-24
00858688006285TENS 8000EMS-DT7202B2016-09-08
00858688006704TMR-ELTH-8500A85002016-10-14
00858688006964Electrode 45 x 45 16 PKELEC0019B2023-09-20
00858688006971Electrode 1.75 x 1.75 4 pack ELEC0008B2023-09-20
00859718007074Electrode 1.75 x 1.75 - 24 PKELEC0028B2023-09-20
00859718007081Electrode 4.0 x 7.0- DispersiveELEC407001B2023-09-20
00859718007098Electrode 1 Inch Round 4 PKSRELEC0001B2023-09-20
00859718007104"Electrode 2"" round 4pk"SRELEC0002B2023-09-20
00859718007111Electrode 3 Inch Round 4PKSRELEC0003B2023-09-20
00859718007135Electrode 2 x 4 Inch Rectangle SRELEC0005B2023-09-20
00859718007142Electrode 2 x 2 inch Square 4PKSRELC0015B2023-09-20
00859718007159Electrode 1.75 Inch SquareSRELEC0016B2023-09-20
00859718007289Flex-MI with ElectrodesFLEMC00012023-09-20
00859718007272Flex-MIFLEMC00012023-09-19
00858688006001Flex-TENSFLET00012016-09-02
00858688006018Flex-ITFLEI00012016-09-02
00858688006025Flex-MT PlusFLEMP00012016-09-02

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