Myotrac 3 Unit

Basic Information

• Brand Name: Myotrac 3 Unit
• Primary DI: 07540191000494
• Version / Model: SA9900
• Company Name: Technologie de Pensée Ltée
• Labeler DUNS: 209284132
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-29
• Public Version: 2
• Public Version Date: 2019-11-20
• Public Version Status: Update
• Public Device Record Key: 9a6e73b4-3b24-422c-883f-4df95816b04d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIR	Perineometer	Obstetrics/Gynecology	884.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46624	Pelvic floor muscle exerciser	A manual device used by women to provide Kegel exercise (alternate contraction and relaxation of perineal muscles) to treat urinary stress incontinence, sexual dysfunction, or to tone the muscles of the pelvic floor. It is typically inserted into the vagina and is available in a variety of designs that commonly includes a spring-loaded, split, cantilevered cylinder that requires the voluntary contraction of the vagina to squeeze it together, or a solid metal, profiled weight that is gripped by the vaginal muscles as gravity pulls it downward. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540191000494	GS1

Premarket Submissions

Submission Number	Supplement Number
K925681	000