INTONEMV
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 Intonemv.
Pre-market Notification Details
| Device ID | K134020 |
| 510k Number | K134020 |
| Device Name: | INTONEMV |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | INCONTROL MEDICAL, LLC 3225 GATEWAY ROAD, SUITE 250 Brookfield, WI 53045 |
| Contact | Jessica Andreshak |
| Correspondent | Jessica Andreshak INCONTROL MEDICAL, LLC 3225 GATEWAY ROAD, SUITE 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 | 2013-12-30 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851508007080 | K134020 | 000 |
| 00851508007059 | K134020 | 000 |
| 00851508007011 | K134020 | 000 |
Trademark Results [INTONEMV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTONEMV 87952950 not registered Live/Pending |
InControl Medical, LLC 2018-06-07 |
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