Cleared Traditional

K872815 - TRANSJAW(TM)

K872815 is an FDA 510(k) clearance for TRANSJAW(TM), manufactured by Vitek, Inc.. The device is a Class 1 Physical Medicine device with 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

FDA 510(k) Submission Details - K872815

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.

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
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