The following data is part of a premarket notification filed by Aime Medical Inc with the FDA for Slim Up Ultra.
Device ID | K151722 |
510k Number | K151722 |
Device Name: | Slim UP ULTRA |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | AIME MEDICAL INC 1258 WEST BAY DRIVE, SUITE F Largo, FL 33770 |
Contact | Paul Guilbaud |
Correspondent | John O'brien AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2015-06-25 |
Decision Date | 2016-03-18 |
Summary: | summary |