The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Quadraplegic Walking Aid.
Device ID | K772267 |
510k Number | K772267 |
Device Name: | QUADRAPLEGIC WALKING AID |
Classification | Cane |
Applicant | MEDFUSION SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPS |
CFR Regulation Number | 890.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-09 |
Decision Date | 1977-12-20 |