Cleared Traditional

K942310 - DYNASTY GC 12550 (GELL/CELL)
(FDA 510(k) Clearance)

K942310 · Foley & Lardner · Physical Medicine device

Nov 1994

Decision

178d

Days

Class 1

Risk

K942310 is an FDA 510(k) clearance for the DYNASTY GC 12550 (GELL/CELL). This device is classified as a Components, Wheelchair (Class I - General Controls, product code KNN).

Submitted by Foley & Lardner (Washington, US). The FDA issued a Cleared decision on November 7, 1994, 178 days after receiving the submission on May 13, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3920.

Submission Details

510(k) Number	K942310 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 13, 1994
Decision Date	November 07, 1994
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement