E-Fit Infinity System (EF-2090 Controller And EF-100 Unit)

Stimulator, Muscle, Powered, For Muscle Conditioning

Fit-Pro Ltd.

The following data is part of a premarket notification filed by Fit-pro Ltd. with the FDA for E-fit Infinity System (ef-2090 Controller And Ef-100 Unit).

Pre-market Notification Details

Device IDK202148
510k NumberK202148
Device Name:E-Fit Infinity System (EF-2090 Controller And EF-100 Unit)
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Fit-Pro Ltd. 7 Szabadsag Ter Budapest,  HU 1054
ContactJanos Papp
CorrespondentJanos Papp
Fit-Pro Ltd. 7 Szabadsag Ter Budapest,  HU 1054
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2021-08-25

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