The following data is part of a premarket notification filed by Electric Mobility Corp. with the FDA for Rascal We Go 250 Powered Wheelchair.
Device ID | K092130 |
510k Number | K092130 |
Device Name: | RASCAL WE GO 250 POWERED WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | ELECTRIC MOBILITY CORP. 1 MOBILITY PLAZA Sewell, NJ 08080 |
Contact | W. Stephen Beversluis |
Correspondent | W. Stephen Beversluis ELECTRIC MOBILITY CORP. 1 MOBILITY PLAZA Sewell, NJ 08080 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-15 |
Decision Date | 2009-09-21 |
Summary: | summary |