PeriCoach®
GUDID 09338067000581
The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. The PeriCoach® device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user’s pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device.
STRATOS MEDTECH PTY LTD
Perineometer| Primary Device ID | 09338067000581 |
| NIH Device Record Key | eabe6dc9-7c83-4f50-b398-7e4df8b8005b |
| Commercial Distribution Discontinuation | 2032-04-11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeriCoach® |
| Version Model Number | PC0100 |
| Company DUNS | 751072256 |
| Company Name | STRATOS MEDTECH PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com | |
| Phone | 1-844-205-0767 |
| help@pericoach.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09338067000581 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160758
FDA Product Code
| HIR | Perineometer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-07-12 |
| Device Publish Date | 2017-04-10 |
Trademark Results [PeriCoach]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERICOACH 79135113 4607665 Live/Registered |
Analytica Limited 2013-07-22 |
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