Device
LSO Heating & Cooling Back Brace L0639/L0651
Manufacturer
INNOVATIVE MEDICAL EQUIPMENT, LLC
Model: 003-51 Catalog: 003-51 DI: 00854682001981 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-24 Current Version: 2026-05-04
Description
LSO Heating & Cooling Back Brace L0639/L0651
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 8fbbea69-fc4e-4dfc-9a77-b12ece0f9369
Distribution Status: In Commercial Distribution
DUNS Number: 833969186
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00854682001981
Type: Primary
Issuing Agency: GS1
GMDN
Code:
Name:
FDA Product Codes
ILO
Pack, Hot Or Cold, Water Circulating
IPY
Orthosis, Lumbo-Sacral
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value: 60
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value: 85
Storage Handling - Storage Handling Type: Storage Environment Temperature