Cleared Traditional

K973914 - SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR

K973914 · Sense Technology, Inc. · Physical Medicine device
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Jun 1998
Decision
259d
Days
-
Risk

K973914 is an FDA 510(k) clearance for the SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Sense Technology, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 30, 1998 after a review of 259 days - an extended review cycle.

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 - K973914

510(k) Number K973914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date June 30, 1998
Days to Decision 259 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
143d slower than avg
Panel avg: 116d · This submission: 259d
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

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K973914 · SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
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