The following data is part of a premarket notification filed by L & M Resource Information Service, Inc. with the FDA for Elevating And Removable Leg And Removable Arm Wheelchair.
Device ID | K964932 |
510k Number | K964932 |
Device Name: | ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | L & M RESOURCE INFORMATION SERVICE, INC. 1860 N.E. 124TH ST. Miami, FL 33166 |
Contact | Manuel J Aguirre |
Correspondent | Manuel J Aguirre L & M RESOURCE INFORMATION SERVICE, INC. 1860 N.E. 124TH ST. Miami, FL 33166 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-09 |
Decision Date | 1997-03-17 |