RT200

GUDID FA211762

RESTORATIVE THERAPIES, INC.

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: FA211762
• NIH Device Record Key: 201a7fc9-1d9a-45c0-a29b-e57ece9b3359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RT200
• Version Model Number: RT200-SLA
• 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	FA211762 [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