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InTone®MV 5000000A1

by Incontrol Medical, LLC

InTone®MV 5000000A1 is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K134020 on 25 Feb 2014 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 00851508007011), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K134020

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851508007011 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK134020 Date25 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K134020 decided 25 Feb 2014 Active
  • FDA GUDID UDI-DI 00851508007011 listed 3 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K134020
  2. Listed FDA GUDID 00851508007011

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
InTone®MV
Generic name
Perineal orifice incontinence-control electrical stimulation system probe, reusable
Model / Ref / Catalog
5000000A1
Primary DI / UDI-DI
00851508007011
510(k) Number
FDA product code
KPI
GMDN term
Perineal orifice incontinence-control electrical stimulation system probe, reusable
Device class
Class II
Regulation number
876.5320
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 51.4 Inch

Related devices

Category: Perineal orifice incontinence-control electrical stimulation system probe, reusable

Cleared under the same submission (K134020)

Similar devices

Other devices filed under FDA product code KPI (STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE).

Other devices from Incontrol Medical, LLC

See all devices from Incontrol Medical, LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)