The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Exerciser, Passive, Non Measuring.
Device ID | K830560 |
510k Number | K830560 |
Device Name: | EXERCISER, PASSIVE, NON MEASURING |
Classification | Exerciser, Non-measuring |
Applicant | KAYE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ION |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-23 |
Decision Date | 1983-03-09 |