EMS

GUDID 00199284910331

MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as the abdomen, thighs, and buttocks with preset intensity protocols.

Canadian Pioneer Medical Technology Corporation

Deep-tissue electromagnetic stimulation system, home-use

• Primary Device ID: 00199284910331
• NIH Device Record Key: ee80a218-7183-44ed-a6dd-dc956a1bc80b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMS
• Version Model Number: MagnaCore
• Company DUNS: 204132773
• Company Name: Canadian Pioneer Medical Technology Corporation
• Device Count: 1
• 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: false
• 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	00199284910331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241601

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: 2025-07-08
• Device Publish Date: 2025-06-30

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• 00199284910331 - EMS: 2025-07-08MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as the abdomen, thighs, and buttocks with preset intensity protocols.
• 00199284910331 - EMS: 2025-07-08 MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as
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