Intonemv
by Incontrol Medical, LLC 2 variants
510(k) K134020
Intonemv is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K134020 on 25 Feb 2014, 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 | NumberK134020 | Date25 Feb 2014 | StatusActive |
Official records
- FDA 510(k) database K134020
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- Withdrawn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
Devices cleared under K134020
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| InTone®MV 5000000A1 | 5000000A1 / 5000000A1 | 00851508007011 | Length 51.4 in | On the market |
| InTone®MV by Viveve 5000000A4 | 5000000A4 / 5000000A4 | 00851508007080 | Length 51.4 in | On the market |
| InTone®MV NASP 5000000A1-NASP | 5000000A1-NASP / 5000000A1-NASP | 00851508007059 | Length 51.4 in | On the market |
Similar devices
Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).
- UROSTYM by Laborie Medical Technologies Corp.
- Well-Life Probe Electrode for Stimulation/EMG Probe Model SA by Well-Life Healthcare, Inc.
- HPM-6000UF by BTL Industries, Inc.
- Everyway Incontinence Stimulation System by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- TS-700P CONTROL XP ELECTRICAL STIMULATOR by Myo/Kinetic Systems, Inc.
- Skylark Uro Probe by Skylark Device & Systems Co., Ltd.
- Anal 2 Electrode Stimulation/EMG Probe - W/Stop by Hollister, Inc.
- Liberty Lite Pfs System by Utah Medical Products, Inc.
- Incontinence Treatment Device LT2061 by Shenzhen Dongdixin Technology Co., Ltd.
- Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) by Shenzhen Konmed Technology Co., Ltd.