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K Number
K982096
Device Name
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
Manufacturer
RAPID MFG. CO.
Date Cleared
1999-06-18

(368 days)

Product Code
GXY
Regulation Number
882.1320
Type
Abbreviated
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For USE WITH TEN.S and E.M.S DEVICES Only (This Product is not designed as a monitoring electrode and should not be used for that purpose..) Pre-gelled EleCTRODES TO BE UTILIZED WITH TEN'S OR EMS DEVICE

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, study details, or device performance. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the "Dermastim Plus" and related devices to legally marketed predicate devices. It discusses regulatory classifications, general controls, and contact information for further inquiries.

Therefore, I cannot extract the requested information to fill in the table or answer the specific questions regarding acceptance criteria and the study proving the device meets those criteria.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).