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510(k) Data Aggregation
K Number
K192035Device Name
EvaQMax Smoke Evacuation System
Manufacturer
Bio Protech, Inc.
Date Cleared
2019-08-29
(30 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
Bio Protech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
Device Description
Not Found
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K Number
K152984Device Name
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
Manufacturer
BIO PROTECH, INC.
Date Cleared
2016-06-03
(238 days)
Product Code
IKT, GXZ
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only.
Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.
Device Description
The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.
The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
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K Number
K153019Device Name
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
Manufacturer
BIO PROTECH, INC.
Date Cleared
2016-03-21
(158 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only.
Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only.
Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).
Device Description
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K Number
K143103Device Name
PROPENCIL Smoke Pencil
Manufacturer
BIO PROTECH, INC.
Date Cleared
2015-07-16
(260 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Device Description
PROPENCIL Smoke Evacuation pencil consists of two types of disposable Smoke Evacuation monopolar pencils with finger controlled button switch or rocker switch for cutting and coagulation, and also suction cap, tube, hose are all included. All products are sterile, single-use, and disposable. The method of sterilization is Ethylene Oxide. The finger controlled switch is push button or rocker switch and the blade is an uncoated stainless steel electrode or ceramic coated non-stick blade.
PROPENCIL Smoke Evacuation pencil is designed to work with standard electrosurgical generators utilizing a 3-pin monopolar connection port and smoke evacuation units utilizing 8-to-22 hose connector. The tube is located near the electrode tip.
PROPENCIL Smoke Evacuation pencil is available with either a push button or a rocker switch, and some models include an optional holster. Most importantly the suction cap can be replaced with longer ones to extend the length of smoke pencil. The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.
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K Number
K142099Device Name
CUTANEOUS ELECTRODES
Manufacturer
BIO PROTECH, INC.
Date Cleared
2014-11-17
(108 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
Device Description
Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
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K Number
K111270Device Name
REUSABLE STIMULATING ELECTRODES
Manufacturer
BIO PROTECH, INC.
Date Cleared
2011-09-13
(133 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.
Electrical stimulation current applications of these electrodes are:
- Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a)
- b) Electrical muscle stimulation (EMS)
- C) Functional electrical stimulation (FES)
- d) Microcurrent electrical nerve stimulation (MENS)
- Interferential stimulation (IF) e)
- f) Neuromuscular electrical stimulation (NMES)
Device Description
Reusable Stimulating Electrodes
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K Number
K100246Device Name
MAX-IF1000
Manufacturer
BIO PROTECH, INC.
Date Cleared
2010-11-24
(301 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
Device Description
MAX-IF1000 Interferential Stimulator
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K Number
K091248Device Name
MAXEMS, MODELS 1000 AND 2000
Manufacturer
BIO PROTECH, INC.
Date Cleared
2009-11-30
(216 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Relax muscles
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis
6. Maintaining or increasing range of motion
Device Description
The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.
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K Number
K092732Device Name
PROPENCIL ESU PENCIL
Manufacturer
BIO PROTECH, INC.
Date Cleared
2009-11-25
(82 days)
Product Code
GEI, DEV
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.
Device Description
The PROPENCIL ESU pencil (and as also to be offered for sale under various private label trade names) is intended for standard electrosurgical operation such as cutting and coagulation. It is designed to work with standard electrosurgical generators. PROPENCIL consists of various types of disposable ESU pencils with hand controlled switch for cutting and coagulation. All of products are sterile device. The method of sterilization is Gamma sterilization. The hand controlled switch is pushbuttons or rocker button and the blade is an uncoated stainless steel electrode or non-stick coated stainless steel electrode.
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K Number
K092761Device Name
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
Manufacturer
BIO PROTECH, INC.
Date Cleared
2009-11-24
(76 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BIO PROTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROPLATE is a disposable, single-use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.
Device Description
PROPLATE Electrosurgical Grounding Plate
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