FDA.reportPublic FDA data

Tailback2-56

Primary DI
00810113682716
Brand
Tailback2-56
Company
Manamed, Inc.
Model
TB056-2
Catalog number
TB056-2
Device description
The Tailback2-56 is a universal thoracic-lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Padded shoulder straps make applying the brace quick and easy. The thoracic extension telescopes to various heights to insure proper fits for all anatomy.Easy application, universal sizeRemovable ice packLightweight, latex free breathable materialDouble pulley system
Published
2025-09-19
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
IPTOrthosis, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113682716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113682716008101136827168101136827160810113682716

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
084042331
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113688473ManaMed IncManaMed Ultrasound Coupling GelMANAGEL012022-12-31
00810113684154ManaEZ Wrist Left, Extra Large EZW3908L-XLEZW3908L-XL2025-10-17
00810113684161ManaEZ Wrist Left, Extra SmallEZW3908L-XSEZW3908L-XS2025-10-17
00810113684178ManaEZ Wrist Right, Extra Large EZW3908R-XLEZW3908R-XL2025-10-17
00810113684185ManaEZ Wrist Right, Extra SmallEZW3908R-XSEZW3908R-XS2025-10-17
00810113682969"ManaEZ Single Panel Knee Immobilizer 18"""EZIMM01-18EZIMM01-182025-11-25
00810113682976"ManaEZ Single Panel Knee Immobilizer 20"""EZIMM01-20EZIMM01-202025-11-25
00810113682983"ManaEZ Single Panel Knee Immobilizer 24"""EZIMM01-24EZIMM01-242025-11-25
00810113682990"ManaEZ 3 Panel Knee Immobilizer 18"""EZ3PIMM01-18EZ3PIMM01-182025-11-25
00810113683003"ManaEZ 3 Panel Knee Immobilizer 20"""EZ3PIMM01-20EZ3PIMM01-202025-11-25
00810113683010"ManaEZ 3 Panel Knee Immobilizer 24"""EZ3PIMM01-24EZ3PIMM01-242025-11-25
00810113683294"ManaEZ 3 Panel Knee Immobilizer 16"""EZ3PIMM01-16EZ3PIMM01-162025-11-25
00810113682600ManaMed IncManaEZ Ice Wrist EZIWST012022-10-13
00850998008119ManaMedManaEZ Wrist Universal RightEZW3908R2022-06-20
00850998008126ManaMedManaEZ Wrist Universal LeftEZW3908L2022-06-20
00810113683065ManaEZ ROM Ice ShortEZR001-XSMEZR001-XSM2025-10-17
00810113683515ManaEZ Hip Ice CureTechEZHIP01B-CTEZHIP01B-CT2025-10-03
00810113683522ManaEZ ROM Ice CureTechEZR001-CTEZR001-CT2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechEZSHLD-CTEZSHLD-CT2025-10-03
00810113683577ManaEZ Ice Long Duration KneeEZLDIP-KNEZLDIP-KN2025-11-25

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
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
04823097722329"TM ""Rehabilitimed"" OT-1V-U Lp Comfort"REABILITIMED TOVIPT2025-05-17