SOLEX THERAPEUTIC PAD

Pad, Heating, Powered

INTL. DIATHERMICS RESEARCH, INC.

The following data is part of a premarket notification filed by Intl. Diathermics Research, Inc. with the FDA for Solex Therapeutic Pad.

Pre-market Notification Details

Device IDK861383
510k NumberK861383
Device Name:SOLEX THERAPEUTIC PAD
ClassificationPad, Heating, Powered
Applicant INTL. DIATHERMICS RESEARCH, INC. 6470 RIVERVIEW TERRACE N.E. Minneapolis,  MN  55432
ContactConstance G Bundy
CorrespondentConstance G Bundy
INTL. DIATHERMICS RESEARCH, INC. 6470 RIVERVIEW TERRACE N.E. Minneapolis,  MN  55432
Product CodeIRT  
CFR Regulation Number890.5740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-14
Decision Date1986-04-18

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