FDA.reportPublic FDA data

The Body Furnace

Primary DI
00082161062004
Brand
The Body Furnace
Company
BROWNMED, INC.
Model
06200
Device description
Personal heating device
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00082161062004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161062004000821610620040821610620040082161062004

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
091999771
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00082161600008IMAK RSI600002020-08-26
00082161600107IMAK RSI600102020-08-26
00082161600206IMAK RSI600202020-08-26
00082161605003IMAK RSI605002020-08-26
00649833101128IMAK RSIA101122020-08-26
00649833103122IMAK RSIA103122020-08-26
00649833201309IMAK CompressionA201302020-08-26
00649833201316IMAK CompressionA201312020-08-26
00649833201323IMAK CompressionA201322020-08-26
00082161300113Polar Ice300112020-08-12
00082161300120Polar Ice300122020-08-12
00082161300137Polar Ice300132020-08-12
00082161300144Polar Ice300142020-08-12
00082161300366Polar Ice300362020-08-12
00082161301004Polar Ice301002020-08-12
00082161301011Polar Ice301012020-08-12
00082161301028Polar Ice301022020-08-12
00082161301035Polar Ice301032020-08-12
00082161301042Polar Ice301042020-08-12
00082161301059Polar Ice301052020-08-12

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00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
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