The following data is part of a premarket notification filed by Bruno Independent Living Aids, Inc. with the FDA for Bruno Elan Stairway Elevator.
| Device ID | K113308 |
| 510k Number | K113308 |
| Device Name: | BRUNO ELAN STAIRWAY ELEVATOR |
| Classification | Transport, Patient, Powered |
| Applicant | BRUNO INDEPENDENT LIVING AIDS, INC. 1780 EXECUTIVE DR. Oconomowoc, WI 53066 |
| Contact | Terrence O'brien |
| Correspondent | Terrence O'brien BRUNO INDEPENDENT LIVING AIDS, INC. 1780 EXECUTIVE DR. Oconomowoc, WI 53066 |
| Product Code | ILK |
| CFR Regulation Number | 890.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-02-01 |