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510(k) Data Aggregation
K Number
K983228Device Name
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
Manufacturer
MURRAY ELECTRONICS
Date Cleared
1999-03-15
(181 days)
Product Code
NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
MURRAY ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionicare Stimulator System Model BIO-1000" is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffiess associated with pain, from rheumatoid arthritis of the hand.
Device Description
The Bionicare Stimulator System, Model BIO-1000" is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. Electrodes are applied to the hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.
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K Number
K971437Device Name
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
Manufacturer
MURRAY ELECTRONICS
Date Cleared
1997-07-22
(95 days)
Product Code
NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
MURRAY ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionicare® Stimulator System Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (see clinical studies).
Device Description
The Bionicare® Stimulator, Model BIO-1000 is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 + 5 Hertz. Electrodes are applied to the knee and thigh using a standard electrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08), The signal is applied across the cathodic knee electrode and the anodic thigh electrode.
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