InTone®MV 5000000A1
GUDID 00851508007011
InToneMV
INCONTROL MEDICAL, LLC
Perineal orifice incontinence-control electrical stimulation system electrode| Primary Device ID | 00851508007011 |
| NIH Device Record Key | ad05b665-7316-45da-a2a3-613514a85412 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InTone®MV |
| Version Model Number | 5000000A1 |
| Catalog Number | 5000000A1 |
| Company DUNS | 052247990 |
| Company Name | INCONTROL MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com | |
| Phone | +1(262)373-0422 |
| info@incontrolmedical.com |
Device Dimensions
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
| Length | 51.4 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851508007011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K134020
FDA Product Code
| KPI | STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-20 |
| Device Publish Date | 2016-10-03 |
Devices Manufactured by INCONTROL MEDICAL, LLC
| 00851508007103 - Attain | 2019-03-27 Attain |
| 00851508007004 - InTone® | 2019-03-20 InTone |
| 00851508007011 - InTone®MV | 2019-03-20InToneMV |
| 00851508007011 - InTone®MV | 2019-03-20 InToneMV |
| 00851508007028 - Apex® | 2019-03-20 Apex |
| 00851508007035 - Apex®M | 2019-03-20 ApexM |
| 00851508007042 - InTone® NASP | 2019-03-20 InTone NASP |
| 00851508007059 - InTone®MV NASP | 2019-03-20 InToneMV-NASP |
| 00851508007073 - InTone® by Viveve | 2019-03-20 InTone by Viveve |
Trademark Results [InTone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTONE 85263563 4206932 Live/Registered |
InControl Medical, LLC 2011-03-10 |
 INTONE 75035345 2102073 Live/Registered |
Stamina Products, Inc. 1995-12-21 |
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