FDA.reportPublic FDA data

Richmar TheraTouch

Primary DI
00092237620397
Brand
Richmar TheraTouch
Company
Drive Devilbiss Healthcare
Model
DQSWD2
Device description
DX2 Shortwave Diathermy Clinical Device
Published
2019-02-08
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
IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131899000SW-THERMShenzhen Dongdixin Technology Co., Ltd.2014-03-14IMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092237620397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092237620397000922376203970922376203970092237620397

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system generatorA component of a short-wave therapeutic diathermy system designed to generate electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz applied transcutaneously to provide a deep heat within specific volumes of the body. The energy generated by this device is typically conducted using electrodes placed on the patient's skin across the area to be treated; the energy is passed between the electrode poles to treat pain, muscle spasms, and joint contractures.

Sterilization Methods#

Method table
Method

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
08720618311177Curapuls 670Enraf-Nonius B.V.IMJ2025-09-23
00868924000038Reprieve by RegenesisRegenesis Biomedical, Inc.IMJ2023-08-23
00850886008009Replexa+ DevicePROMEDTEK, INC.IMJ2019-07-08
00850886008016Replexa+ Treatment ApplicatorPROMEDTEK, INC.IMJ2019-07-08
B108703POENUS0100BTL-703BTL INDUSTRIES LIMITEDIMJ2019-04-16
04053815055174ThermoProZimmer MedizinSysteme GmbHIMJ2016-12-16
00888912187848CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187855CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187909CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187916CHATTANOOGADJO, LLCIMJ2016-09-15
00888912188050CHATTANOOGADJO, LLCIMJ2016-09-15
00888912188685CHATTANOOGADJO, LLCIMJ2016-09-15
00888912253949CHATTANOOGADJO, LLCIMJ2016-09-15
00888912335645CHATTANOOGADJO, LLCIMJ2016-09-15
00816864020180Auto*Therm 390METTLER ELECTRONICS CORP.IMJ2016-09-15
00816864020531Drum Applicator 3980METTLER ELECTRONICS CORP.IMJ2016-09-15
00888912187831CHATTANOOGADJO, LLCIMJ2016-09-12
00888912253772CHATTANOOGADJO, LLCIMJ2016-09-12
00858703006078Megapulse IIACCELERATED CARE PLUS CORPIMJ2016-08-16
00858703006085Megapulse III/OmniSWDACCELERATED CARE PLUS CORPIMJ2016-08-16