DIGI-PRO TENS MODEL WL-2203 AND WL-2205

Stimulator, Nerve, Transcutaneous, For Pain Relief

WELL-LIFE HEALTHCARE, INC.

The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for Digi-pro Tens Model Wl-2203 And Wl-2205.

Pre-market Notification Details

Device IDK021359
510k NumberK021359
Device Name:DIGI-PRO TENS MODEL WL-2203 AND WL-2205
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant WELL-LIFE HEALTHCARE, INC. NO. 5 ALLEY 5 LANE CHENG HSING CHUNG CHING RD., PEI TUN DIST. Taichung,  TW
ContactTony C.s. Chang
CorrespondentTony C.s. Chang
WELL-LIFE HEALTHCARE, INC. NO. 5 ALLEY 5 LANE CHENG HSING CHUNG CHING RD., PEI TUN DIST. Taichung,  TW
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-30
Decision Date2002-04-30
Summary:summary

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