NeuroMD RS-18-MD

GUDID 04719872332480

NeuroMD RS-18 Wireless Muscle Stimulator

ZMI ELECTRONICS LTD.

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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• 04719872333302 - Levina: 2024-02-27 Self-adhesive electrode, butterfly + round type (Pink)
• 04719872333319 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type (Pink)
• 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)