Cleared Traditional

K884976 - MICRO-STRAIGHT POSTURE TRAINING DEVICE

K884976 · Mcdowell Ent., Inc. · Physical Medicine device
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Jun 1989
Decision
191d
Days
-
Risk

K884976 is an FDA 510(k) clearance for the MICRO-STRAIGHT POSTURE TRAINING DEVICE. Classified as Monitor, Spine Curvature (product code LZW).

Submitted by Mcdowell Ent., Inc. (Kansas City, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 191 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 Mcdowell Ent., Inc. devices

FDA 510(k) Submission Details - K884976

510(k) Number K884976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date June 09, 1989
Days to Decision 191 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

LZW Device Classification - Class 0,

Product Code LZW Monitor, Spine Curvature
Device Class -