TheraFace

Basic Information

• Brand Name: TheraFace
• Primary DI: 00810036056724
• Version / Model: TheraFace PRO Black
• Company Name: Theragun, Inc
• Labeler DUNS: 080550811
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-18
• Public Version: 1
• Public Version Date: 2022-01-26
• Public Version Status: New
• Public Device Record Key: 463306b9-d876-49a1-9e04-b88f8476ef87

Device Description

The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2
IRO	Vibrator, Therapeutic	Physical Medicine	890.5975	1
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	882.5890	2
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	878.4810	2
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	No	Active
61169	Transcutaneous electrical stimulation probe	A non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810036056724	GS1