FDA.reportPublic FDA data

Curapuls 670

Primary DI
08720618311177
Brand
Curapuls 670
Company
Enraf-Nonius B.V.
Model
1670931
Device description
Shortwave diathermy device
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K243112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243112000Curapuls 670Enraf-Nonius, B.V.2025-06-25IMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720618311177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720618311177087206183111778720618311177

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system, professionalAn assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The device is intended to be operated by healthcare provider in a clinical setting, typically to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414024224
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720618311139Sonopuls 49414989412025-02-11
08809308380782Compact-II34422082025-09-23
08719992508174EN-Dynamic Chest Press14559512025-02-11
08719992508181EN-Dynamic Back Trainer14559522025-02-11
08719992508198EN-Dynamic Pull Down14559532025-02-11
08719992508204EN-Dynamic Abdominal Trainer14559542025-02-11
08719992508211EN-Dynamic Leg Extension14559552025-02-11
08719992508228EN-Dynamic Rowing14559562025-02-11
08719992508235EN-Dynamic Shoulder Press14559572025-02-11
08719992508242EN-Dynamic Adduction14559582025-02-11
08719992508259EN-Dynamic Abduction14559592025-02-11
08719992508266EN-Dynamic Fly14559602025-02-11
08719992508273EN-Dynamic Total Hip14559612025-02-11
08719992508280EN-Dynamic Seated Leg Curl14559622025-02-11
08719992508297EN-Dynamic Seated Leg Press14559632025-02-11
08719992508303EN-Dynamic Triceps Dips14559642025-02-11
08719992508310EN-Dynamic Squat14559652025-02-11
08719992508327EN-Dynamic Rotator14559662025-02-11
08720618311108Sonopuls 19016319512025-02-11
08720618311153Endolaser 12016339312025-02-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850886008016Replexa+ Treatment ApplicatorPROMEDTEK, INC.IMJ2019-07-08
B108703POENUS0100BTL-703BTL INDUSTRIES LIMITEDIMJ2019-04-16
00092237620397Richmar TheraTouch Drive Devilbiss HealthcareIMJ2019-02-08
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