FDA.reportPublic FDA data

EMFACE controller

Primary DI
B108785APMMUS10
Brand
EMFACE controller
Company
BTL INDUSTRIES LIMITED
Model
BTL-785-7
Published
2023-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
NUWStimulator, Muscle, Powered, Dental
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
NUWStimulator, Muscle, Powered, DentalPhysical Medicine2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108785APMMUS10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality hyperthermia systemA mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using multiple energy sources, for the treatment of malignant or benign tumours, or other disease conditions. It includes a patient-end applicator, software, and a multi-modality generator(s)/control unit. It is intended to achieve whole-body and localized heating of tissues using two or more energy sources [e.g., ultrasound, radio-frequency (RF), microwave, circulating heated fluid] through either externally-mounted components, or from catheter- or probe-type applicators inserted endoscopically or surgically.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
733532951
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B108398AP1MA3MUS00Chair Applicator398-AP-MA-32026-08-27
B108398PO11MUS00EMSELLA DUOEMSELLA DUO2026-08-27
B108890POAMUS00BTL-890UBTL-890U2026-08-26
B108699APM1MUS00EXOMIND Dual applicatorBTL-699-AP-M-12026-08-25
B108660POMUS00R-GAITR-GAIT2026-03-19
B108899PO11C1ENUS0150EMSCULPT NEOEMSCULPT NEO2024-09-23
B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108699PO3M2MUS00BTL-699 EXOMINDBTL-699 EXOMIND2025-04-04
B108699BELTMEU00BeltBelt2024-11-06
B108699HEADRESTMEU00HeadrestHeadrest2024-11-06
B108699APM2MUS00EXOMIND applicatorBTL-699-AP-M-22024-08-28
B108699PO2M2MUS00EXOMINDEXOMIND2024-08-28
B108043PO30WMUS00LS-6000LS-60002024-03-22
B108451POSCAEL2MUS00Scanning System for LS-6000Scanning System for LS-60002024-03-22
B108A299AP13ENUS1020BTL Chair ApplicatorBTL Chair Applicator2019-02-25
B108D099PO130ENUS1030BTL EMSELLABTL EMSELLA2019-02-25
B108899AP2C2MUS20Small applicator899-AP-C-22023-12-08
B108899AP2C45MUS10Edge applicatorEdge applicator2023-12-08
B108899APC1ENUS0140Large applicator899-AP-C-12023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDPBX2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18