STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER

Exerciser, Powered

ORTHOPEDIC DEVELOPMENT, INC.

The following data is part of a premarket notification filed by Orthopedic Development, Inc. with the FDA for Stretchpower(tm) Brand Of Stretch Loading Exerciser.

Pre-market Notification Details

Device IDK934175
510k NumberK934175
Device Name:STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER
ClassificationExerciser, Powered
Applicant ORTHOPEDIC DEVELOPMENT, INC. 1700 SOUTH PARK ST., SUITE 201 Kalamazoo,  MI  49001
ContactAlan A Halpern
CorrespondentAlan A Halpern
ORTHOPEDIC DEVELOPMENT, INC. 1700 SOUTH PARK ST., SUITE 201 Kalamazoo,  MI  49001
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-26
Decision Date1994-03-24

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