Cleared Traditional

NEW-STIM SPINAL ADJUSTMENT INSTRUMENT (K944369) - FDA 510(k) Clearance

K944369 · Lawrence E. Newsum, DC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
231d
Days
-
Risk

K944369 is an FDA 510(k) clearance for the NEW-STIM SPINAL ADJUSTMENT INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Lawrence E. Newsum, DC (Lomita, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 231 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 Lawrence E. Newsum, DC devices

Submission Details

510(k) Number K944369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date April 26, 1995
Days to Decision 231 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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