InTone
Stimulator, Electrical, Non-implantable, For Incontinence
INCONTROL MEDICAL, LLC.
The following data is part of a premarket notification filed by Incontrol Medical, Llc. with the FDA for Intone.
Pre-market Notification Details
| Device ID | K150180 |
| 510k Number | K150180 |
| Device Name: | InTone |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | INCONTROL MEDICAL, LLC. 3225 GATEWAY ROAD, STE. 250 Brookfield, WI 53045 |
| Contact | Jessica Andreshak |
| Correspondent | Jessica Andreshak INCONTROL MEDICAL, LLC. 3225 GATEWAY ROAD, STE. 250 Brookfield, WI 53045 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-03-16 |
| Summary: | summary |
Trademark Results [InTone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTONE 85263563 4206932 Live/Registered |
InControl Medical, LLC 2011-03-10 |
 INTONE 75035345 2102073 Live/Registered |
Stamina Products, Inc. 1995-12-21 |
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