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510(k) Data Aggregation
K Number
K172381Device Name
Digitimer DS7AP Constant Current Stimulator
Manufacturer
Digitimer Ltd.
Date Cleared
2018-03-06
(211 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Digitimer Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.
Device Description
The DS7AP Constant Current Stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Peña, "Pull-through" or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique.
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K Number
K051357Device Name
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
Manufacturer
DIGITIMER LTD.
Date Cleared
2005-09-20
(119 days)
Product Code
GWF
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
DIGITIMER LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DS7A and DS7AH are stimulators intended for use during neurological monitoring and assessment in a clinical environment. They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.
Device Description
The Digitimer DS7A Stimulator provides constant current high voltage pulses of brief duration for percutancous stimulation during investigation of the electrical activity of nerve and muscle tissue. The output current is continuously variable over the range 0 to 100 milliamps, from a source voltage continuously variable from less than 100 volts to 400 volts, to meet the requirements of human pathological cases. Short pulse durations have been made available to minimise any discomfort to the subject. The pulse width range can be varied from 50 microsconds to 2 milliscconds in six steps. A specially designed isolated output stage maintains a square (current) pulse shape while minimising stimulus artefacts. The Digitimer DS7AH Stimulator is a variant of the DS7A providing a higher maximum current at reduced pulse width. This option is offered to overcome the difficulty of stimulating deep peripheral nerves with large area electrode pads. The DS7AH option will provide a maximum stimulus current of 1 amp at up to 400 volts compliance at pulse widths up to 200 us.
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