FDA.reportPublic FDA data

Thermophore Deluxe

Primary DI
00040337012666
Brand
Thermophore Deluxe
Company
Battle Creek Equipment Co.
Model
F00266
Device description
Medium Thermophore Deluxe II
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00040337012666PackageGS112In Commercial Distribution
00040337002667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00040337012666000403370126660403370126660040337012666
00040337002667000403370026670403370026670040337002667

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001957422
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00040337001530ThermophoreF001532024-10-22
00040337007709Embrace™ Relief Wrap BackF007702020-12-14
00040337007716Embrace™ Relief Wrap KneeF007712020-12-14
00040337007723Embrace™ Relief Wrap ShoulderF007722020-12-14
00040337007730Embrace™ Relief Wrap NeckF007732020-12-14
00040337001561Max Heat ThermophoreF001562017-01-04
00040337001745MuffF001742017-01-04
00040337001776Max Heat ThermophoreF001772017-01-04
00040337002254Thermophore FreedomF002252017-01-04
00040337002261Thermophore FreedomF002262017-01-04
00040337002278Thermophore FreedomF002272017-01-04
00040337002353Thermophore FreedomF002352017-01-04
00040337002360Thermophore FreedomF002362017-01-04
00040337002452Thermophore DeluxeF002452017-01-04
00040337002469Thermophore DeluxeF002462017-01-04
00040337002476Thermophore DeluxeF002472017-01-04
00040337002551Thermophore PlusF002552017-01-04
00040337002568Thermophore PlusF002562017-01-04
00040337002667Thermophore DeluxeF002662017-01-04
00040337002674Thermophore DeluxeF002672017-01-04

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00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00041298991960DMID-M-S HOLDINGS, INC.IRT2025-06-12
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