MAGSCULPT

GUDID 08809956800151

K1MEDGLOBAL Co.,Ltd.

Deep-tissue electromagnetic stimulation system, professional

• Primary Device ID: 08809956800151
• NIH Device Record Key: 33b82bc4-f327-4c6b-87b6-450fb3c78dbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGSCULPT
• Version Model Number: MST-1001
• Company DUNS: 987628867
• Company Name: K1MEDGLOBAL Co.,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: 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	08809956800151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222400

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: 2025-03-21
• Device Publish Date: 2025-03-13

Devices Manufactured by K1MEDGLOBAL Co.,Ltd.

• 08809956800144 - CORESCULPT: 2025-03-21
• 08809956800151 - MAGSCULPT: 2025-03-21
• 08809956800151 - MAGSCULPT: 2025-03-21