FDA.report

Therasound EVO

Primary DI
00850958007107
Brand
Therasound EVO
Company
Compass Richmar, LLC
Model
410-028
Device description
Therasound EVO (220V)
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code Classifications

CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850958007107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007107008509580071078509580071070850958007107

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
080930531
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10850958007159GelShotGSA2CH12016-11-23
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10850689007343STICK-E-PADS203-6752016-11-18
10850689007350STICK-E-PADS203-6732016-11-18
10850689007367STICK-E-PADS203-6722016-11-18
10850689007374STICK-E-PADS203-6802016-11-18
10850689007381STICK-E-PADS203-6812016-11-18
10850689007398STICK-E-PADS203-6762016-11-18
10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

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