Levina SAE-MPBFPK2

GUDID 04719872333395

Self-adhesive electrode, round type (Pink)

ZMI ELECTRONICS LTD.

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 ID: 04719872333395
• NIH Device Record Key: 49009dcf-38ed-45f2-a5f8-2765c77b7ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Levina
• Version Model Number: SAE-MPBFPK2
• Catalog Number: SAE-MPBFPK2
• Company DUNS: 657406062
• Company Name: ZMI ELECTRONICS LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	04719872333395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220997

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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