FDA.reportPublic FDA data

Therasound EVO

Primary DI
00850958007084
Brand
Therasound EVO
Company
Drive Devilbiss Healthcare
Model
400-020
Device description
Therasound 3.5P
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850958007084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007084008509580070848509580070840850958007084

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
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true
Manufacturing date on label
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
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.IMI2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.IMI2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.IMI2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.IMI2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.IMI2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.IMI2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00850998008546ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
08720618311108Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
08720618311221Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
00850030915191RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMI2023-08-02
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22