The following data is part of a premarket notification filed by Brookefield Hunter, Inc. with the FDA for Walk N Chair.
Device ID | K935211 |
510k Number | K935211 |
Device Name: | WALK N CHAIR |
Classification | Wheelchair, Mechanical |
Applicant | BROOKEFIELD HUNTER, INC. 880 N. MAIN ST. Oregon, WI 53575 |
Contact | Ron Erfurth |
Correspondent | Ron Erfurth BROOKEFIELD HUNTER, INC. 880 N. MAIN ST. Oregon, WI 53575 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-29 |
Decision Date | 1994-02-02 |