Cleared Traditional

COMPACT WHEELCHAIR PLATFORM

K101723 · Design Specific Fletcher · Physical Medicine

Dec 2010

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K101723 is an FDA 510(k) clearance for the COMPACT WHEELCHAIR PLATFORM, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Design Specific Fletcher (Ringmer East Sussex, GB). The FDA issued a Cleared decision on December 23, 2010, 188 days after receiving the submission on June 18, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.

Submission Details

510(k) Number	K101723 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2010
Decision Date	December 23, 2010
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF