Cleared Traditional

K882413 - SUBOCCIPITAL ICE PILLOW (FDA 510(k) Clearance)

Class I Physical Medicine device.

K882413 · Ferguson Medical · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
170d
Days
Class 1
Risk

K882413 is an FDA 510(k) clearance for the SUBOCCIPITAL ICE PILLOW. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 170 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5700 - the FDA physical medicine device framework. 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 Ferguson Medical devices

Submission Details

510(k) Number K882413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1988
Decision Date November 30, 1988
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IME Pack, Hot Or Cold, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.