ReBuilder

GUDID 00866650000308

Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical device that relieves chronic pain by calming erratic nerve signals, strengthening muscles, and restoring local blood flow.

REBUILDER MEDICAL INC.

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 00866650000308
• NIH Device Record Key: c511753f-ddea-4d23-adcf-c00362d6043b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReBuilder
• Version Model Number: 2407
• Company DUNS: 831001404
• Company Name: REBUILDER MEDICAL 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 304-725-2202
• Email: accounting@rebuildermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866650000308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874085

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-12-28

On-Brand Devices [ReBuilder]

• 00866650000315: Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical dev
• 00866650000308: Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical dev