Levina

Basic Information

• Brand Name: Levina
• Primary DI: 04719872334033
• Version / Model: RS-48
• Catalog Number: RS-48
• Company Name: ZMI ELECTRONICS LTD.
• Labeler DUNS: 657406062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2026-04-14
• Public Version: 1
• Public Version Date: 2026-04-22
• Public Version Status: New
• Public Device Record Key: 0e74dfae-48c8-409a-a4d5-5e80db4fcc98

Device Description

Levina Pelvic Floor Muscle Stimulator (RS-48)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65013	Perineal orifice incontinence-control electrical stimulation system, home-use	A device or device assembly available for use by a patient/layperson outside a clinical setting designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., hand-held remote control) intended for wired or wireless connection to a cylinder-like probe with surface electrodes designed to be inserted into the vagina and/or anus; the probe may be included in the device assembly. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04719872333982	GS1		2	In Commercial Distribution
Primary	04719872334033	GS1
Unit of Use	04719872334040	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241862	000