Healthpal

GUDID 06974000130002

Xiamen Healthpal Electronic Co., Ltd.

Hand-held deep-tissue electromagnetic stimulator

• Primary Device ID: 06974000130002
• NIH Device Record Key: 905e907b-458b-43ca-a89c-eea6aad57473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthpal
• Version Model Number: FE-0161
• Company DUNS: 553874367
• Company Name: Xiamen Healthpal Electronic 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06974000130002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211850

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2025-01-13
• Device Publish Date: 2025-01-04

On-Brand Devices [Healthpal]

• 06974000130026: FE-7513
• 06974000130019: FE-7204B
• 06974000130002: FE-0161