Cleared Traditional

JAMES LECKEY PRONE STANDER

K944307 · James Leckey Design · Physical Medicine

Dec 1994

Decision

111d

Days

Class 1

Risk

About This 510(k) Submission

K944307 is an FDA 510(k) clearance for the JAMES LECKEY PRONE STANDER, a Table, Mechanical (Class I — General Controls, product code INW), submitted by James Leckey Design (Waltham, US). The FDA issued a Cleared decision on December 22, 1994, 111 days after receiving the submission on September 2, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3750.

Submission Details

510(k) Number	K944307 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 1994
Decision Date	December 22, 1994
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement