Cleared Traditional

SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR (K973914) - FDA 510(k) Clearance

K973914 · Sense Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Sense Technology, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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