Cleared Traditional

HAMEX TWO (K951028) - FDA 510(k) Clearance

Class I Physical Medicine device.

K951028 · Northern Orthopaedic Products, Inc. · Physical Medicine device
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Dec 1995
Decision
279d
Days
Class 1
Risk

K951028 is an FDA 510(k) clearance for the HAMEX TWO. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Northern Orthopaedic Products, Inc. (Hamden, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 279 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Northern Orthopaedic Products, Inc. devices

Submission Details

510(k) Number K951028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date December 11, 1995
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
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.