Levina RS-18

GUDID 04719872332022

Levina RS-18 Wireless TENS/EMS Stimulator

ZMI ELECTRONICS LTD.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04719872332022
• NIH Device Record Key: e5d3c82b-8637-4864-b0bc-c9c08521990b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Levina
• Version Model Number: RS-18
• Catalog Number: RS-18
• Company DUNS: 657406062
• Company Name: ZMI ELECTRONICS LTD.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: false

Customer Support Contacts

• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com
• Phone: +88678150053
• Email: mail@zmi-electronics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872332022 [Package]; Contains: 04719872332039; Package: Box [3 Units]; In Commercial Distribution
GS1	04719872332039 [Primary]
GS1	04719872332046 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220997

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [Levina ]

• 04719872333395: Self-adhesive electrode, round type (Pink)
• 04719872333371: Self-adhesive electrode, butterfly type: D53x111mm (Blue)
• 04719872333357: Self-adhesive electrode, butterfly type: D68x141mm (Blue)
• 04719872333319: Self-adhesive electrode, butterfly type (Pink)
• 04719872333302: Self-adhesive electrode, butterfly + round type (Pink)
• 04719872333296: Self-adhesive electrode, butterfly type: D68x141mm + D53x111mm (Blue)
• 04719872332107: Levina RS-38 Menstrual Pain Relief Stimulator
• 04719872332022: Levina RS-18 Wireless TENS/EMS Stimulator