FDA.reportPublic FDA data

BTL Cellutone

Primary DI
B108744POCTENUS0
Brand
BTL Cellutone
Company
BTL INDUSTRIES LIMITED
Model
BTL Cellutone
Published
2017-01-12
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
IROVibrator, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IROVibrator, TherapeuticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108744POCTENUS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B108660POMUS00R-GAITR-GAIT2026-03-19
B108899PO11C1ENUS0150EMSCULPT NEOEMSCULPT NEO2024-09-23
B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108785APMMUS10EMFACE controllerBTL-785-72023-06-28
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
B108899PO11C1ENUS0140EMSCULPT NEOEMSCULPT NEO2023-12-08
B108785PO8MUS00BTL-785FBTL-785F2023-12-01
B108785PO9MUS00BTL-785FBTL-785F2023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRO2025-07-15
07898939912272AvaBoots 5.0AVANUTRI EQUIPAMENTOS DE SAUDE LTDAIRO2025-06-25
00810140061423RENPHOJoicom CorporationIRO2024-11-19
00810140061430RENPHOJoicom CorporationIRO2024-11-19
00810140061515RENPHOJoicom CorporationIRO2024-11-19
10810140061420RENPHOJoicom CorporationIRO2024-11-19
10810140061437RENPHOJoicom CorporationIRO2024-11-19
10810140061512RENPHOJoicom CorporationIRO2024-11-19
00840295405568TherabodyTherabody, Inc.IRO2024-11-08
00840295405575TherabodyTherabody, Inc.IRO2024-11-08
00840295405582TherabodyTherabody, Inc.IRO2024-11-08
07290103039653VSA 2 Hand HeldMEDOC LTD.IRO2023-06-20
07290103039660VSA 2 Handheld deviceMEDOC LTD.IRO2023-06-20
07290103039677VSA 2 Hand-Leg supportMEDOC LTD.IRO2023-06-20
00810036056687TheraFaceTherabody, Inc.IRO2022-01-18
00810036056724TheraFaceTherabody, Inc.IRO2022-01-18
00813859002886PretikaPRETIKA CORPORATIONIRO2020-04-30
00813859002619PretikaPRETIKA CORPORATIONIRO2019-07-01
B108714GUNALXC0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
B108714GUNALXCENUS0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
07290103039004VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24
07290103039509VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24