FDA.reportPublic FDA data

Roscoe Medical

Primary DI
00092237616741
Brand
Roscoe Medical
Company
Drive Devilbiss Healthcare
Model
DQ9275
Device description
SoundCare Plus - Professional
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120217000SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.2012-11-21IMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237616747PackageGS13In Commercial Distribution
00092237616741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761674780092237616747
00092237616741000922376167410922376167410092237616741

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

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