Omron Max Power Relief PM3032

GUDID 00073796330323

Electrotherapy Pain Relief TENS Unit

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00073796330323
• NIH Device Record Key: 26b0be6f-1548-4eb1-a89e-2f8f6c66cd0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Max Power Relief
• Version Model Number: PM3032
• Catalog Number: PM3032
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• 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: false
• 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: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796330323 [Primary]
GS1	10073796330320 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	40073796330321 [Package]; Package: boxes of 3 units [2 Units]; In Commercial Distribution
GS1	50073796330328 [Package]; Package: boxes of 3 units [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141978

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-05-17

On-Brand Devices [Omron Max Power Relief]

• 00073796330323: Electrotherapy Pain Relief TENS Unit
• 00073796303235: Electrotherapy Pain Relief TENS Unit