FDA.reportPublic FDA data

ThermaZone

Primary DI
00854682001967
Brand
ThermaZone
Company
INNOVATIVE MEDICAL EQUIPMENT, LLC
Model
003-48
Catalog number
003-48
Device description
LSO Heating & Cooling Back Brace L0631/L0648
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating
IPYOrthosis, Lumbo-Sacral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854682001967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854682001967008546820019678546820019670854682001967

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, reusableA device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature60 Degrees Fahrenheit85 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
877-901-9663customerservice@imeconcepts.com

Regulatory Flags#

DUNS number
833969186
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854682001974ThermaZone003-50003-502026-04-24
00854682001981ThermaZone003-51003-512026-04-24
00854682001035ThermaZone003-13003-132026-02-18
00854682001912ThermaZone003-31003-312025-09-05
00854682001356ThermaZone003-99003-992022-02-03
00854682001950ThermaZone003-47003-472020-12-01
00854682001028ThermaZone003-12003-122016-09-24
00854682001042ThermaZone 003-10003-102016-09-24
00854682001110ThermaZone003-15003-152016-09-24
00854682001127ThermaZone003-20003-202016-09-24
00854682001134ThermaZone003-17003-172016-09-24
00854682001141ThermaZone003-18003-182016-09-24
00854682001158ThermaZone003-19003-192016-09-24
00854682001301ThermaZone003-11003-112016-09-24
00854682001349ThermaZone003-22003-222016-09-24
00854682001486ThermaZone003-27003-272016-09-24
00854682001493ThermaZone003-28003-282016-09-24
00854682001509ThermaZone003-29003-292016-09-24
00854682001523ThermaZone003-26003-262016-09-24
00854682001578ThermaZone 003-07003-072016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
00810113683492ManaMomma Maternity Back BraceManamed, Inc.IPY2025-10-03
00810113683508ManaMomma Maternity Back Brace, Custom Label Manamed, Inc.IPY2025-10-03
00810113683546Tailback2-50 CureTechManamed, Inc.IPY2025-10-03
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
07798094540825WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540832WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540849WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540856WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540863WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540870WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540887WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540894WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540900WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094540917WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094541020WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094541037WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094541044WELLBRACEPANTYMED S.A.IPY2024-01-08
07798094541051WELLBRACEPANTYMED S.A.IPY2024-01-08
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15