BODYFLEX MASSAGER

Massager, Therapeutic, Electric

TRURO'S ENT.

The following data is part of a premarket notification filed by Truro's Ent. with the FDA for Bodyflex Massager.

Pre-market Notification Details

Device IDK952041
510k NumberK952041
Device Name:BODYFLEX MASSAGER
ClassificationMassager, Therapeutic, Electric
Applicant TRURO'S ENT. 760 DALGLIESH DR. Egina, Saskatchewan,  CA S4r 6g2
ContactDerek Parnell
CorrespondentDerek Parnell
TRURO'S ENT. 760 DALGLIESH DR. Egina, Saskatchewan,  CA S4r 6g2
Product CodeISA  
CFR Regulation Number890.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-01
Decision Date1995-08-14

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