FDA.reportPublic FDA data

BON CHARGE

Primary DI
09361725000098
Brand
BON CHARGE
Company
BLUBLOX PTY LTD
Model
PEMF Wrap
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09361725000098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09361725000098093617250000989361725000098

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
745074558
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09361725000142BON CHARGECold & Heat Therapy Massage Gun2024-12-23
09361725000159BON CHARGEInfrared PEMF Sauna Dome2024-12-23
09361725000005BON CHARGEBullet Red Light Therapy Device2024-12-17
09361725000012BON CHARGEDemi Red Light Therapy Device2024-12-17
09361725000029BON CHARGEMax Red Light Therapy Device2024-12-17
09361725000036BON CHARGESuper Max Red Light Therapy Device2024-12-17
09361725000043BON CHARGERed Light Face Mask2024-12-17
09361725000050BON CHARGERed Light Neck and Chest Mask2024-12-17
09361725000067BON CHARGERed Light Therapy Blanket2024-12-17
09361725000074BON CHARGEMini Red Light Therapy Device2024-12-17
09361725000081BON CHARGERed Light Face Wand2024-12-17
09361725000104BON CHARGEPEMF Mat Mini2024-12-17
09361725000111BON CHARGEPEMF Mat Demi2024-12-17
09361725000128BON CHARGEPEMF Mat Max2024-12-17
09361725000135BON CHARGESauna Blanket2024-12-17

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Primary DI, Brand, Company table
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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
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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
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