Yarlap I

GUDID 00860000860000

The Yarlap® device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Relevium Labs, Inc.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00860000860000
NIH Device Record Keydfa95b35-947d-44c1-88fc-d515da0c4553
Commercial Distribution StatusIn Commercial Distribution
Brand NameYarlap I
Version Model NumberECS 323
Company DUNS080316407
Company NameRelevium Labs, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com
Phone6145687000
Emailb.reider@releviumlabs.com

Device Dimensions

Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter
Height108 Millimeter
Width62 Millimeter
Depth23 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000860000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPIStimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-07

Devices Manufactured by Relevium Labs, Inc.

00860000860000 - Yarlap I2023-10-16The Yarlap® device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
00860000860000 - Yarlap I2023-10-16 The Yarlap® device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitati
00860000860031 - Yarlap II2023-10-16 The Yarlap® device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitati

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