Identity
- Trade Name
- InTone®MV FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI
- Device Name
- InToneMV FDA UDI
- Model / Reference
- 5000000A1 FDA UDI
- Description
- InToneMV FDA UDI
Identifiers
- Catalog Number
- 5000000A1 FDA UDI
- Primary DI / UDI-DI
- 00851508007011 FDA UDI
- 510(k) Number
- K134020 FDA UDI
- FDA Product Code
- KPI FDA UDI
- GMDN Term
- Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 51.4 Inch FDA UDI
Category: Perineal orifice incontinence-control electrical stimulation system probe, reusable
InTone®MV by Incontrol Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Perineal orifice incontinence-control electrical stimulation system probe, reusable.
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- Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · Class II
Cleared under the same submission
K134020 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Incontrol Medical, Llc
Sources (1)
- FDA UDI ad05b665-7316-45da-a2a3-613514a85412 38 fields · synced May 30, 2026