FDA.reportPublic FDA data

Ultratone

Primary DI
05056119700008
Brand
Ultratone
Company
ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED
Model
Futura Pro (US Specification)
Catalog number
USFPC1
Device description
Futura Pro (US Specification) System comprising: Console, Body Applicator, and 1MHz Ultrasound Applicator.
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056119700008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056119700008050561197000085056119700008

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
226427250
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720618311139Sonopuls 494Enraf-Nonius B.V.IMG2025-02-11
00190446748427CHATTANOOGADJO, LLCIMG2023-10-27
00190446750611CHATTANOOGADJO, LLCIMG2023-10-27
00190446750628CHATTANOOGADJO, LLCIMG2023-10-27
00190446780304CHATTANOOGADJO, LLCIMG2023-09-04
00190446780311CHATTANOOGADJO, LLCIMG2023-09-04
00190446780328CHATTANOOGADJO, LLCIMG2023-09-04
00190446780335CHATTANOOGADJO, LLCIMG2023-09-04
00858703006139OmniVersaACCELERATED CARE PLUS CORPIMG2023-08-17
00850030915191RichmarSouth Dakota Partners Inc.IMG2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMG2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMG2023-08-02
00190446780601CHATTANOOGADJO, LLCIMG2023-04-25
00190446780618CHATTANOOGADJO, LLCIMG2023-04-25
00092237623817TheraTouch UX2Drive Devilbiss HealthcareIMG2022-09-07
00190446750598CHATTANOOGADJO, LLCIMG2022-09-02
00190446750604CHATTANOOGADJO, LLCIMG2022-09-02
00190446757214CHATTANOOGADJO, LLCIMG2022-09-02
00190446757221CHATTANOOGADJO, LLCIMG2022-09-02
08908008085413Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDIMG2021-06-04
08908008085420Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDIMG2021-06-04
00092237902523Winner Evo CM2 - 120VDrive Devilbiss HealthcareIMG2019-11-05
00092237901052CM4 Winner Evo Device - 220VDrive Devilbiss HealthcareIMG2018-09-27
00092237901069Winner Evo CM2 - 120VDrive Devilbiss HealthcareIMG2018-09-27
00092237901076Winner Evo CM2 - 220VDrive Devilbiss HealthcareIMG2018-09-27
00092237901120AutoSound Hands Free US ApplicatorDrive Devilbiss HealthcareIMG2018-09-27
00850958007619WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007909WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007916WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007923WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21