Cleared Traditional

K872815 - TRANSJAW(TM)

K872815 is the FDA 510(k) clearance for TRANSJAW(TM) by Vitek, Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K872815 · Vitek, Inc. · Physical Medicine device
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Jan 1988
Decision
187d
Days
Class 1
Risk

K872815 is an FDA 510(k) clearance for the TRANSJAW(TM). Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Vitek, Inc. (Houston, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 187 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 Vitek, Inc. devices

Submission Details

510(k) Number K872815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date January 19, 1988
Days to Decision 187 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
72d slower than avg
Panel avg: 115d · This submission: 187d
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.

Regulatory Peers - BXB Exerciser, Powered

All 31
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K872815.
MOTORIZED PARALLEL BAR, MODEL 110
K882916 · Tri W-G, Inc. · Jul 1988
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K880865 · Invacare Corp. · May 1988
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100
K880092 · Invacare Corp. · Apr 1988
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
K872586 · Invacare Corp. · Sep 1987
MOTORIZED TREADMILL MODEL #FT2200
K872638 · Invacare Corp. · Sep 1987
DELUXE MOTORIZED TREADMILL MODEL #FT2300
K872639 · Invacare Corp. · Sep 1987