Tailback2-42 TB042-2

GUDID 00810113682693

The Tailback2-42 is a universal spinal orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a low profile, comfortable, and quick fitting solution for patient. Ice pack included. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system

Manamed, Inc.

Lumbar spine orthosis
Primary Device ID00810113682693
NIH Device Record Key86b27e80-107d-44a3-9ced-3639a3a19cc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTailback2-42
Version Model NumberTB042-2
Catalog NumberTB042-2
Company DUNS084042331
Company NameManamed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113682693 [Primary]

FDA Product Code

IQEOrthosis, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-29
Device Publish Date2025-09-19

Devices Manufactured by Manamed, Inc.

00810113682730 - ManaSlide2025-12-03 ManaSlide is a patient transfer blanket designed to assist in patient positioning in a bed or for moving a patient from a bed to
00810113682969 - ManaEZ Single Panel Knee Immobilizer 18"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682976 - ManaEZ Single Panel Knee Immobilizer 20"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682983 - ManaEZ Single Panel Knee Immobilizer 24"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682990 - ManaEZ 3 Panel Knee Immobilizer 18"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683003 - ManaEZ 3 Panel Knee Immobilizer 20"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683010 - ManaEZ 3 Panel Knee Immobilizer 24"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683072 - Extension Panel - Zynex Pro Hybrid LSO 6372025-12-03 The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar orthosis designed with our patent pending chord compression system wit

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.