Xcite

GUDID FA216218

RESTORATIVE THERAPIES, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: FA216218
• NIH Device Record Key: d75fa8ff-ef40-492e-ada2-b93ce87a961b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcite
• Version Model Number: Xcite clinical station
• 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	FA216218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160614

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: 6
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-12-21

Devices Manufactured by RESTORATIVE THERAPIES, INC.

• FA109136 - RT200: 2019-12-02
• FA211762 - RT200: 2019-12-02
• FA216218 - Xcite: 2019-12-02
• FA216218 - Xcite: 2019-12-02
• FA100052 - RT300: 2019-05-23
• FA102011 - RT300: 2019-05-23
• FA104581 - RT300: 2019-05-23
• FA109080 - RT300: 2019-05-23
• FA211509 - RT600: 2019-05-23