Cleared Traditional

K921446 - HOT OR COLD PACK (THERMIPAQ) (FDA 510(k) Clearance)

K921446 · Thermionics Corp. · Physical Medicine device

Jul 1992

Decision

108d

Days

Class 1

Risk

K921446 is an FDA 510(k) clearance for the HOT OR COLD PACK (THERMIPAQ). This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).

Submitted by Thermionics Corp. (Springfield, US). The FDA issued a Cleared decision on July 13, 1992, 108 days after receiving the submission on March 27, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.

Submission Details

510(k) Number	K921446 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1992
Decision Date	July 13, 1992
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement