The following data is part of a premarket notification filed by Bruno Independent Living Aids, Inc. with the FDA for The Bruno Powerbase, Model Psb-2200.
Device ID | K991954 |
510k Number | K991954 |
Device Name: | THE BRUNO POWERBASE, MODEL PSB-2200 |
Classification | Wheelchair, Powered |
Applicant | BRUNO INDEPENDENT LIVING AIDS, INC. 1780 EXECUTIVE DR. Oconomowoc, WI 53066 |
Contact | William W Belson Iii |
Correspondent | William W Belson Iii BRUNO INDEPENDENT LIVING AIDS, INC. 1780 EXECUTIVE DR. Oconomowoc, WI 53066 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-10 |
Decision Date | 1999-11-02 |