Cleared Traditional

K912086 - FMA TRANSLATOR

K912086 is an FDA 510(k) clearance for FMA TRANSLATOR, manufactured by Normandie Group, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K912086 · Normandie Group, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
86d
Days
Class 1
Risk

K912086 is an FDA 510(k) clearance for the FMA TRANSLATOR. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Normandie Group, Inc. (Montgomery, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Normandie Group, Inc. devices

FDA 510(k) Submission Details - K912086

510(k) Number K912086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date August 07, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 39
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K912086.
ARTROMOT SB ELBOW ATTACHMENT
K923857 · Buckman Co., Inc. · Feb 1993
DANNINFLEX CPM 800
K923216 · Buckman Co., Inc. · Aug 1992
DANNIFLEX CPM 2000
K923217 · Buckman Co., Inc. · Aug 1992
DANNIFLEX MODEL 500TM CPM
K904735 · Buckman Co., Inc. · Jan 1991
CLUB FOOT CPM MACHINE
K903851 · Smith & Nephew Richards, Inc. · Oct 1990
ARTROMOT(TM) CPM DEVICES
K895015 · Buckman Co., Inc. · Sep 1989