The following data is part of a premarket notification filed by Walk-a-cycle Division with the FDA for Walk-a-cycle.
Device ID | K820711 |
510k Number | K820711 |
Device Name: | WALK-A-CYCLE |
Classification | Walker, Mechanical |
Applicant | WALK-A-CYCLE DIVISION 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 | 1982-03-15 |
Decision Date | 1982-04-08 |