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510(k) Data Aggregation
K Number
K131513Device Name
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
Manufacturer
Date Cleared
2014-07-11
(409 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
RITM OKB ZAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.
Device Description
The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories. The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.
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K Number
K092117Device Name
SCENAR, MODEL 10
Manufacturer
Date Cleared
2010-05-28
(318 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RITM OKB ZAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.
Device Description
SCENAR transcutaneous electrostimulators are designed for delivering general noninvasive treatment via human skin areas for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. SCENAR devices generate low and medium frequency bipolar electric pulses. The shape of the pulses dynamically varies with changing electrophysiological characteristics of the skin. The device has an upper cover, case with a built-in electrode and a battery cover. All components except for the batteries are located on the printed circuit board inside the device's case. The device's controls and visual indicators are located on the upper side of its case.
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