510(k) K854354

THE BLEDSOE PASSIVE MOTION EXERCISER by Medical Technology and Innovations, Inc. — Product Code BXB

K854354 is an FDA 510(k) premarket notification submitted by Medical Technology and Innovations, Inc. for the device "THE BLEDSOE PASSIVE MOTION EXERCISER". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Medical Technology and Innovations, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
October 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type