Cleared Traditional

SPINE TUNER POSTURE TRAINER (K951244) - FDA 510(k) Clearance

K951244 · Dan Kline · Physical Medicine device
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Jun 1995
Decision
105d
Days
-
Risk

K951244 is an FDA 510(k) clearance for the SPINE TUNER POSTURE TRAINER. Classified as Monitor, Spine Curvature (product code LZW).

Submitted by Dan Kline (Carlsbad, US). The FDA issued a Cleared decision on June 26, 1995 after a review of 105 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.

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Submission Details

510(k) Number K951244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date June 26, 1995
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZW Monitor, Spine Curvature
Device Class -