FDA.reportPublic FDA data

Tailback2-64

Primary DI
00810113682723
Brand
Tailback2-64
Company
Manamed, Inc.
Model
TB064-2
Catalog number
TB064-2
Device description
The Tailback2-64 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, spine motion restriction, comfortable, and quick fitting solution for every patient. Ice pack included.Easy application, universal sizeTLSO Thoracic bar with height adjustmentsLightweight, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPTOrthosis, Thoracic
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113682723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113682723008101136827238101136827230810113682723

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

Contacts#

Phone, Email table
PhoneEmail
888-508-0712support@manamed.com

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
00810113682730ManaSlideMSLIDEMSLIDE012025-11-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04068903520939MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520946MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520953MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520960MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520977MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
06979144490449Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490456Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490463Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490470Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490487Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
00810178889648CoreTechVIVE HEALTH LLCIQE2026-08-19
06979144490241Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490258Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490265Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490272Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490289Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490296Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490302Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490319Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490326Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490333Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490340Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490357Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490364Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490371Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490388Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490395Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490401Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490418Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490425Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18