AccessGUDID - DEVICE: Yarlap II (00860000860031)

GUDID

Device Identifier (DI) Information

Brand Name: Yarlap II
Version or Model: ECS 323P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Relevium Labs, Inc.

Primary DI Number: 00860000860031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080316407 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160773	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 132 Millimeter
Height: 68 Millimeter

Device Record Status

Public Device Record Key: a3d947b1-6521-4403-85c2-a6fc269ed1ee
Public Version Date: October 16, 2023
Public Version Number: 1
DI Record Publish Date: October 07, 2023