TrueRelief

GUDID B731P12S0

Truerelief, LLC

Transcutaneous electrical stimulation probe

• Primary Device ID: B731P12S0
• NIH Device Record Key: c11ba55c-dd89-4e08-9da3-33405d3376ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueRelief
• Version Model Number: P12S
• Company DUNS: 117175267
• Company Name: Truerelief, LLC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B731P12S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202186

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2024-01-15
• Device Publish Date: 2024-01-05

On-Brand Devices [TrueRelief]

• B731WW120: WW12
• B731TR1250C0: TR1250C
• B731P12S0: P12S
• B731P12P0: P12P
• B73112500: 1250