Healy

GUDID 04251784906088

This device is a variant of the Healy device with primary DI number 04251784906033. This device is available in obsidian color instead of the standard white color.

Healy GmbH

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04251784906088
• NIH Device Record Key: fa4289ef-f4ab-41c8-8654-9a3632b5d493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healy
• Version Model Number: 0006
• Company DUNS: 314161135
• Company Name: Healy GmbH
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251784906088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191075

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [Healy]

• 04251784906033: 0006
• 04251784906088: This device is a variant of the Healy device with primary DI number 04251784906033. This device