FDA.reportPublic FDA data

N/A

Primary DI
80092237616440
Brand
N/A
Company
Roscoe Medical
Model
DQ8000W5
Device description
5cm Sound Head - 2nd Gen
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
80092237616440PackageGS120Not in Commercial Distribution
00092237616444PrimaryGS10
00092337616443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761644080092237616440
00092237616444000922376164440922376164440092237616444
00092337616443000923376164430923376164430092337616443

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
022542271
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
80092237604225Wheelchair Foam Cushion - 22 x 18 x 3WCBF-22832020-11-11
80092237604232Wheelchair Foam Cushion - 24 x 18 x 3WCBF-24832020-11-11
80092237604300Wheelchair Back Cushion Foam - 16 x 17BKF-16172020-11-11
80092237604317Wheelchair Back Cushion Foam - 18 x 17BKF-18172020-11-11
80092237604324Wheelchair Back Cushion Foam - 20 x 19BKF-20192020-11-11
80092237604331Wheelchair Back Cushion Foam - 22 x 19BKFB-22192020-11-11
80092237604270Coccyx Cushion Memory Foam - 18 x 16 x 3COC-182020-11-11
80092237605468N/ADQ78442016-10-12
80092237611629N/ADQ84502016-10-12
80092237616655N/ADE75022016-10-12
80092237616686N/ADI47382016-10-12
80092237616709N/ADI81952016-10-12
80092237616754N/ADS22022016-10-12
80092237616761N/ADS50022016-10-12
80092237617515N/ADI37172016-10-12
80813520010772N/ADT30022016-10-12
80813520011939N/ADI10102016-10-12
60092237603118Roscoe Medical500402016-10-05
80092237603181Roscoe Medical500182016-10-07
60092237603316Roscoe Medical32012016-10-07

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Primary DI, Brand, Company table
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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
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00190446750604CHATTANOOGADJO, LLCIMG2022-09-02
00190446757214CHATTANOOGADJO, LLCIMG2022-09-02
00190446757221CHATTANOOGADJO, LLCIMG2022-09-02
08908008085413Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDIMG2021-06-04
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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
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