Cleared Traditional

K974376 - JTECH ADJUSTER REFLEX GUN

K974376 · J-Tech Medical, Inc. · Physical Medicine device
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Feb 1998
Decision
90d
Days
-
Risk

K974376 is an FDA 510(k) clearance for the JTECH ADJUSTER REFLEX GUN. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by J-Tech Medical, Inc. (Crofton, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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.

FDA 510(k) Submission Details - K974376

510(k) Number K974376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date February 18, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

Product Code LXM Manipulator, Plunger-like Joint
Device Class -

Regulatory Peers - LXM Manipulator, Plunger-like Joint

All 30
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ACTIVATOR II
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SMART ADJUSTER (SA201)
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INTEGRATOR
K950646 · Moyco Union Broach, Div., Moyco Technologies, Inc. · Apr 1996
K974376 · JTECH ADJUSTER REFLEX GUN
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