The following data is part of a premarket notification filed by 21st Century Scientific, Inc. with the FDA for Sidekick Power Wheelchair.
Device ID | K954044 |
510k Number | K954044 |
Device Name: | SIDEKICK POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | 21ST CENTURY SCIENTIFIC, INC. 4915 INDUSTRIAL WAY Coeur D' Alene, ID 83815 |
Contact | Ronald E Prior |
Correspondent | Ronald E Prior 21ST CENTURY SCIENTIFIC, INC. 4915 INDUSTRIAL WAY Coeur D' Alene, ID 83815 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-29 |
Decision Date | 1995-10-13 |