Cleared Traditional

K944369 - NEW-STIM SPINAL ADJUSTMENT INSTRUMENT

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.

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FDA 510(k) Submission Details - K944369

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.

LXM Device Classification - Class 0,

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