Cleared Traditional

K951028 - HAMEX TWO

K951028 is an FDA 510(k) clearance for HAMEX TWO, manufactured by Northern Orthopaedic Products, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 279-day FDA review.

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

FDA 510(k) Submission Details - K951028

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.

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
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