Cleared Traditional

SPIFFY

K945650 · Thames Valley Children'S Centre · Physical Medicine

Dec 1994

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K945650 is an FDA 510(k) clearance for the SPIFFY, a Chair, Adjustable, Mechanical (Class I — General Controls, product code INN), submitted by Thames Valley Children'S Centre (London Ontario N6c 5y6, CA). The FDA issued a Cleared decision on December 19, 1994, 32 days after receiving the submission on November 17, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number	K945650 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1994
Decision Date	December 19, 1994
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement