Search Results
Found 3 results
510(k) Data Aggregation
K Number
K192234Device Name
ActiPatch
Manufacturer
BioElectronics Corporation
Date Cleared
2020-01-31
(165 days)
Product Code
PQY
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
BioElectronics Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adjunctive treatment of musculoskeletal pain
Device Description
The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.
Ask a Question
K Number
K190251Device Name
RecoveryRx
Manufacturer
BioElectronics Corporation
Date Cleared
2019-06-28
(141 days)
Product Code
ILX
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
BioElectronics Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adjunctive treatment of postoperative pain
Device Description
The RecoveryRx® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.
Ask a Question
K Number
K152432Device Name
ActiPatch(R)
Manufacturer
BIOELECTRONICS CORPORATION
Date Cleared
2017-02-03
(526 days)
Product Code
PQY
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
BIOELECTRONICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.
Device Description
The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.
Ask a Question
Page 1 of 1