Cleared Traditional

MARK IV HAND, THUMB AND WRIST (CPM) UNIT (K894907) - FDA 510(k) Clearance

Class I Physical Medicine device.

K894907 · Innovative Medical Engineering, Inc. · Physical Medicine device
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Oct 1989
Decision
66d
Days
Class 1
Risk

K894907 is an FDA 510(k) clearance for the MARK IV HAND, THUMB AND WRIST (CPM) UNIT. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Innovative Medical Engineering, Inc. (Hawthorne, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 66 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 Innovative Medical Engineering, Inc. devices

Submission Details

510(k) Number K894907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date October 06, 1989
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.