Cleared Traditional

MICRO-STRAIGHT POSTURE TRAINING DEVICE (K884976) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LZW Monitor, Spine Curvature
Device Class -