PIVOT ASSIST


Device Classification Name

chair, positioning, electric

510(k) Number K081053
Device Name PIVOT ASSIST
Applicant
PIVOT ASSIST, LLC
9335 mccracken blvd.
garfield hts., 
OH 
44125

Applicant Contact john quigley
Correspondent
PIVOT ASSIST, LLC
9335 mccracken blvd.
garfield hts., 
OH 
44125

Correspodent Contact john quigley
Regulation Number 890.3110
Classification Product Code
INO  
Subsequent Product Code
INM  
Date Received 04/14/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No