Pulse Massager

GUDID 00817746020397

BETTER BASICS, INC.

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• Primary Device ID: 00817746020397
• NIH Device Record Key: 4764d727-3b7f-4e1f-b0c6-328de18eed4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Massager
• Version Model Number: MP-TENS310-US
• Company DUNS: 013029698
• Company Name: BETTER BASICS, 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817746020397 [Primary]
GS1	00817746020403 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00817746020410 [Package]; Contains: 00817746020403; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131921

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-18

On-Brand Devices [Pulse Massager]

• 00817746020915: MP-TENS510-US
• 00817746020397: MP-TENS310-US
• 00817746020366: MP-TENS-110