The following data is part of a premarket notification filed by Lic-orthion with the FDA for Resi-walker.
Device ID | K830848 |
510k Number | K830848 |
Device Name: | RESI-WALKER |
Classification | Walker, Mechanical |
Applicant | LIC-ORTHION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITJ |
CFR Regulation Number | 890.3825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-17 |
Decision Date | 1983-04-05 |