Healy

GUDID 04251784906033

Healy GmbH

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04251784906033
• NIH Device Record Key: aead2da6-35ff-4cfd-8ebe-161477ac11b8
• 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	04251784906033 [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: 2020-03-25
• Device Publish Date: 2020-03-17

On-Brand Devices [Healy]

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