RT200

GUDID FA109136

RESTORATIVE THERAPIES, INC.

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: FA109136
• NIH Device Record Key: a58474b7-03a0-4912-b8c7-b396eb92129a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RT200
• Version Model Number: RT200-SLSA
• Company DUNS: 186976408
• Company Name: RESTORATIVE THERAPIES, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	FA109136 [Primary]

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-09-16

On-Brand Devices [RT200]

• FA211762: RT200-SLA
• FA109136: RT200-SLSA