NeuroMD RS-18-MD

GUDID 04719872332480

NeuroMD RS-18 Wireless Muscle Stimulator

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 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: 04719872332480
• NIH Device Record Key: e5df9f62-a1b2-4798-9a0e-ea9b07e467f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroMD
• Version Model Number: RS-18
• Catalog Number: RS-18-MD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872332480 [Package]; Contains: 04719872332503; Package: Box [3 Units]; In Commercial Distribution
GS1	04719872332497 [Unit of Use]
GS1	04719872332503 [Primary]

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: 2023-06-23
• Device Publish Date: 2023-06-15

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• 04719872333357 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type: D68x141mm (Blue)
• 04719872333371 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type: D53x111mm (Blue)
• 04719872333395 - Levina: 2024-02-27 Self-adhesive electrode, round type (Pink)