Omron Pocket Pain Pro PM3029

GUDID 00073796630294

Electrotherapy Pocket Pain Pro TENS Unit

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00073796630294
• NIH Device Record Key: 9277ff3b-c68e-4793-870f-0a6951172ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Pocket Pain Pro
• Version Model Number: PM3029
• Catalog Number: PM3029
• 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	00073796630294 [Primary]
GS1	10073796630291 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	50073796630299 [Package]; Package: boxes of 3 units [4 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 Pocket Pain Pro]

• 00073796630294: Electrotherapy Pocket Pain Pro TENS Unit
• 10073796634008: TENS Therapy Pain Relief device that relieves Chronic, Acute and Arthritic Pain - 5 Preset modes