Cleared Traditional

K942618 - ANKLE CALF EXERCISER

K942618 is an FDA 510(k) clearance for ANKLE CALF EXERCISER, manufactured by Prevent Products, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K942618 · Prevent Products, Inc. · Physical Medicine device
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Jun 1994
Decision
64d
Days
Class 1
Risk

K942618 is an FDA 510(k) clearance for the ANKLE CALF EXERCISER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Prevent Products, Inc. (W St Paul, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 64 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 Prevent Products, Inc. devices

FDA 510(k) Submission Details - K942618

510(k) Number K942618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date June 22, 1994
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 38
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K942618.
ANKLE CALF EXERCISER PHLEBOPUMP
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ARTROMOT K2 CPM
K931555 · Ormed Mfg., Inc. · Jan 1994