Incontrol
510(k) K110179
Incontrol is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K110179 on 22 Feb 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110179 | Date22 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K110179
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5320
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).
- }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR by Urologics, Inc.
- VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL by Hollister, Inc.
- BTL-299-F by BTL Industries, Inc.
- DETRUSAN 500 by Innovamed USA, Inc.
- Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) by SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
- HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM by Hmt, Inc.
- Regenesis EMS Chair by Trinity Medical Solutions
- LIBERTY RECTAL PELVIC FLOOR EXERCISER by Utah Medical Products, Inc.
- Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes by Zmi Elecronics, Ltd.
- INNOVA RECTAL STIMULATON ELECTRODE by Empi