SHOWER TROLLEY

Lift, Patient, Non-ac-powered

SETMA, INC.

The following data is part of a premarket notification filed by Setma, Inc. with the FDA for Shower Trolley.

Pre-market Notification Details

Device IDK841395
510k NumberK841395
Device Name:SHOWER TROLLEY
ClassificationLift, Patient, Non-ac-powered
Applicant SETMA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFSA  
CFR Regulation Number880.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-03
Decision Date1984-05-07

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