Curapuls 670

Basic Information

• Brand Name: Curapuls 670
• Primary DI: 08720618311177
• Version / Model: 1670931
• Company Name: Enraf-Nonius B.V.
• Labeler DUNS: 414024224
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-23
• Public Version: 1
• Public Version Date: 2025-10-01
• Public Version Status: New
• Public Device Record Key: ae0be7a0-e70d-432f-a9c8-d5dbbf035d60

Device Description

Shortwave diathermy device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45207	Short-wave diathermy treatment system, professional	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720618311177	GS1

Premarket Submissions

Submission Number	Supplement Number
K243112	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 70 Degrees Celsius