The following data is part of a premarket notification filed by Ralston Group with the FDA for Feminine Personal Trainer (fpt).
Device ID | K171896 |
510k Number | K171896 |
Device Name: | Feminine Personal Trainer (FPT) |
Classification | Perineometer |
Applicant | Ralston Group 656 Lake Lanier Rd. Selma, AL 36701 |
Contact | Russell Ralston |
Correspondent | Jennifer Tillman Intertek Surveying Services 16441 Space Center Blvd, Suite D-100 Houston, TX 77058 |
Product Code | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-26 |
Decision Date | 2017-08-29 |
Summary: | summary |