The following data is part of a premarket notification filed by Pro Message Co. with the FDA for Thera-cane.
Device ID | K903820 |
510k Number | K903820 |
Device Name: | THERA-CANE |
Classification | Massager, Therapeutic, Manual |
Applicant | PRO MESSAGE CO. P.O. BOX 9220 445 S. BRYANT STREET Denver, CO 80209 |
Contact | Daniel J Hennessey |
Correspondent | Daniel J Hennessey PRO MESSAGE CO. P.O. BOX 9220 445 S. BRYANT STREET Denver, CO 80209 |
Product Code | LYG |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-20 |
Decision Date | 1990-09-19 |