Cleared Traditional

TI-COMFORTER (K780927) - FDA 510(k) Clearance

K780927 · Alden Products Co. · Physical Medicine device
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Aug 1978
Decision
65d
Days
-
Risk

K780927 is an FDA 510(k) clearance for the TI-COMFORTER.

Submitted by Alden Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 9, 1978 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alden Products Co. devices

Submission Details

510(k) Number K780927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1978
Decision Date August 09, 1978
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -