DEMI-WALKER (REGULAR)

Joint, Knee, External Brace

MEDFUSION SYSTEMS, INC.

The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Demi-walker (regular).

Pre-market Notification Details

Device IDK772268
510k NumberK772268
Device Name:DEMI-WALKER (REGULAR)
ClassificationJoint, Knee, External Brace
Applicant MEDFUSION SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeITQ  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-09
Decision Date1977-12-20

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