RT300

GUDID FA216912

RESTORATIVE THERAPIES, INC.

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: FA216912
• NIH Device Record Key: e99d8444-6a93-4c40-9e1e-7d81ae7bc65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RT300
• Version Model Number: SAGE stimulator
• 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	FA216912 [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: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-16

On-Brand Devices [RT300]

• FA218481: RT300-SA Desktop
• FA218039: RT300-SA
• FA217791: RT300-LA supine
• FA217787: RT300-SLSA Supine
• FA217786: RT300-SLA Supine
• FA216912: SAGE stimulator
• FA216769: RT300-SLP
• FA109080: RT300-LSA
• FA104581: RT300-SLSA
• FA102011: RT300-SLA
• FA100052: RT300-SL