Identity
- Trade Name
- Zynex Pro Hybrid LSO 637 FDA UDI
- Generic Name
- Multiple spinal region orthosis FDA UDI
- Device Name
- The Zynex Pro Hybrid LSO 637 is a universal sacral-lumar 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. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system FDA UDI
- Model / Reference
- 123237 FDA UDI
- Description
- The Zynex Pro Hybrid LSO 637 is a universal sacral-lumar 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. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system FDA UDI
Identifiers
- Catalog Number
- 123237 FDA UDI
- Primary DI / UDI-DI
- 00810113683058 FDA UDI
- FDA Product Code
- IPY FDA UDI
- GMDN Term
- Multiple spinal region orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple spinal region orthosis
Zynex Pro Hybrid LSO 637 by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple spinal region orthosis.
- TM "Rehabilitimed" L-4M-3 XXL Comfort — REABILITIMED TOV · Class I
- Trulife — TRULIFE, INC. · Class I
- Trulife — TRULIFE, INC. · Class I
- Trulife — TRULIFE, INC. · Class I
- TM "Rehabilitimed" L-4M-3 L Comfort — REABILITIMED TOV · Class I
- TM "Rehabilitimed" L-4M-2V XXXL Comfort — REABILITIMED TOV · Class I
- Boston Brace — Boston Brace International, Inc. · Class I
- TM "Rehabilitimed" GL-1 XXL Comfort — REABILITIMED TOV · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 730aa2d6-f44e-420b-8dd9-5daec60af0b6 35 fields · synced May 30, 2026