The following data is part of a premarket notification filed by Windmere Corp. with the FDA for Windmere Prelude Iii.
Device ID | K924237 |
510k Number | K924237 |
Device Name: | WINDMERE PRELUDE III |
Classification | Massager, Therapeutic, Electric |
Applicant | WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
Contact | Dee Eichenberger |
Correspondent | Dee Eichenberger WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-10-18 |