Electromagnetic Stimulator Device

Basic Information

• Brand Name: Electromagnetic Stimulator Device
• Primary DI: 06970453270234
• Version / Model: Tesla Duet
• Company Name: Beijing ADSS Development Co., Ltd.
• Labeler DUNS: 529128739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-30
• Public Version: 1
• Public Version Date: 2025-11-07
• Public Version Status: New
• Public Device Record Key: bf93cec0-49e9-4617-ace3-6878b906ca6a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60820	Electromagnetic abdominal obesity reduction device	A mains electricity (AC-powered) device designed to reduce abdominal obesity through the noninvasive application of low frequency alternating electromagnetic fields; it may also deliver controlled low pressure massage. It may take several forms, including an enveloping suit to cover the abdomen and legs, or straps worn around the waist and thighs, and a connected control unit. The device may be used in the home or in a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970453270234	GS1

Premarket Submissions

Submission Number	Supplement Number
K231318	000