Healy

GUDID 04251784206034

TimeWaver Production GmbH

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04251784206034
• NIH Device Record Key: 3c8023bf-988a-4af0-a073-3e728b2dc0e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healy
• Version Model Number: 0006
• Company DUNS: 341997962
• Company Name: TimeWaver Production 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	04251784206034 [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: 2020-03-18
• Device Publish Date: 2020-03-10

Devices Manufactured by TimeWaver Production GmbH

• 04251784202067 - TimeWaver Frequency: 2022-01-31 TimeWaver Frequency is an electrical stimulation device that supports the treatment of symptoms of specific medical conditions,
• 04251784206034 - Healy: 2020-03-18
• 04251784206034 - Healy: 2020-03-18