FDA.reportPublic FDA data

Replexa+ Treatment Applicator

Primary DI
00850886008016
Brand
Replexa+ Treatment Applicator
Company
PROMEDTEK, INC.
Model
C1416
Device description
Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator
Published
2019-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K162240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162240000ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc.2016-11-17IMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850886008016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850886008016008508860080168508860080160850886008016

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system, home-useAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8663882410info@promedtek.com

Regulatory Flags#

DUNS number
604679527
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850886008009Replexa+ DeviceC14162019-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720618311177Curapuls 670Enraf-Nonius B.V.IMJ2025-09-23
00868924000038Reprieve by RegenesisRegenesis Biomedical, Inc.IMJ2023-08-23
00850886008009Replexa+ DevicePROMEDTEK, 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