Cleared Traditional

K904934 - AUTOMASTER

K904934 · Team Mfg., Inc. · Physical Medicine device
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May 1991
Decision
201d
Days
-
Risk

K904934 is an FDA 510(k) clearance for the AUTOMASTER.

Submitted by Team Mfg., Inc. (Augusta, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 201 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 Team Mfg., Inc. devices

FDA 510(k) Submission Details - K904934

510(k) Number K904934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1990
Decision Date May 21, 1991
Days to Decision 201 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
86d slower than avg
Panel avg: 115d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

IPQ Device Classification - Class ,

Product Code IPQ
Device Class -