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510(k) Data Aggregation
K Number
K003631Device Name
SMARTWAVE IF 2000
Manufacturer
NEWWAVE MEDICAL LLC.
Date Cleared
2001-08-10
(259 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEWWAVE MEDICAL LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993130Device Name
ULTRA-GARMENT ELECTRODE
Manufacturer
NEWWAVE MEDICAL LLC.
Date Cleared
1999-12-17
(88 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEWWAVE MEDICAL LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Ultra Garment Electrode" is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.
ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.
Device Description
The Ultra Garment Electrode is a Stretchable Electrically Conductive glove, sock, or sleeve, Reusable.
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