Extension Panel - Zynex Pro Hybrid LSO 637 123238

GUDID 00810113683072

The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar 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. This device is the extension panel to increase the size of the brace.

Manamed, Inc.

Multiple spinal region orthosis
Primary Device ID00810113683072
NIH Device Record Key22b9e271-7c0c-4b22-bf32-2143b25f9fdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtension Panel - Zynex Pro Hybrid LSO 637
Version Model Number123238
Catalog Number123238
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

Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com
Phone800-495-6670
Emailinfo@zynex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113683072 [Primary]

FDA Product Code

IPYOrthosis, Lumbo-Sacral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-03
Device Publish Date2025-11-25

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00810113683072 - Extension Panel - Zynex Pro Hybrid LSO 6372025-12-03The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar 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. This device is the extension panel to increase the size of the brace.
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