Replexa+ Device

Basic Information

• Brand Name: Replexa+ Device
• Primary DI: 00850886008009
• Version / Model: C1416
• Company Name: PROMEDTEK, INC.
• Labeler DUNS: 604679527
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-08
• Public Version: 1
• Public Version Date: 2019-07-16
• Public Version Status: New
• Public Device Record Key: 5ad6fd6d-4b2f-44c1-be4a-8b9e6409dda5

Device Description

Replexa+ Model C1416 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: Yes
• 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
34668	Short-wave diathermy treatment system, home-use	An assembly of devices designed to be operated by a patient in the home to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency 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. This system is typically used 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	00850886008009	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162240	000