The following data is part of a premarket notification filed by Tropical Enterprises, Inc. with the FDA for Rhythm Wheel.
Device ID | K813497 |
510k Number | K813497 |
Device Name: | RHYTHM WHEEL |
Classification | Device, Fertility Diagnostic, Proceptive |
Applicant | TROPICAL ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-14 |
Decision Date | 1982-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RHYTHM WHEEL 73659884 1469209 Dead/Cancelled |
MYNATT, ALLEN G., JR. 1987-05-11 |
![]() RHYTHM WHEEL 73222190 1162338 Dead/Cancelled |
Brown, Jr.; Ewart F. 1979-07-05 |