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510(k) Data Aggregation
K Number
K151995Device Name
Painmaster MCT Patch
Manufacturer
NEWMARK, INC.
Date Cleared
2016-10-05
(443 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEWMARK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Painmaster MCT Patch is indicated for:
-temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
-symptomatic relief of chronic, intractable pain.
Device Description
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
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K Number
K130114Device Name
PAINMASTER MCT PATCH
Manufacturer
NEWMARK, INC.
Date Cleared
2013-04-16
(90 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEWMARK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Device Description
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
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K Number
K090042Device Name
PAINMASTER MCT PATCH
Manufacturer
NEWMARK, INC.
Date Cleared
2009-05-06
(120 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEWMARK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Device Description
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
Ask a Question
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