EMS-2C

Basic Information

• Brand Name: EMS-2C
• Primary DI: G395EMS2C1
• Version / Model: EMS-2C
• Company Name: Med Labs Inc
• Labeler DUNS: 620223529
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-12
• Public Version: 1
• Public Version Date: 2023-07-20
• Public Version Status: New
• Public Device Record Key: fa906d80-d98e-4cef-a283-4b25534b9e07

Device Description

Electronic Muscle Stimulator Interrupted DC and Pulsed

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66566	Facial muscle cosmesis electrical stimulator	An electrically-powered, hand-held device intended to be used in the home to apply electrical stimuli to the facial muscles through the skin (transcutaneously), to improve muscle tone and help tighten overlying skin for cosmetic facial rejuvenation. It includes electrodes at the distal end and controls to adjust the electrical impulse intensity; it is typically used with a gel, which may be supplied with the device, intended to facilitate conduction of the electrical current. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G395EMS2C1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K960457	000