FDA.reportPublic FDA data

Electromagnetic Stimulator Device

Primary DI
06970453270234
Brand
Electromagnetic Stimulator Device
Company
Beijing ADSS Development Co., Ltd.
Model
Tesla Duet
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231318000Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)Beijing Adss Development Co., Ltd.2023-07-07NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970453270234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970453270234069704532702346970453270234

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic abdominal obesity reduction deviceA 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.

Regulatory Flags#

DUNS number
529128739
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970453270173Diode Laser Therapy MachineFG2000-B2025-10-30
06970453270180Diode Laser Therapy MachineFG2000-B pro2025-10-30
06970453270197Diode Laser Therapy MachineFG2000-D+ 2025-10-30
06970453270203Diode Laser Therapy MachineFG2000-D+pro 2025-10-30
06970453270210Diode Laser Therapy MachineFG2000-E2025-10-30
06970453270227Electromagnetic Stimulator DeviceEM Contouring2025-10-30
06970453270258Intensity Pulsed Light Therapy SystemVE20002025-10-30
06970453270265Intensity Pulsed Light Therapy SystemVE2000 Pro2025-10-30
06970453270272Intensity Pulsed Light Therapy SystemVE2000 Pro0012025-10-30
06970453270289Intensity Pulsed Light Therapy SystemVE2000 Pro0022025-10-30
06970453270296Intensity Pulsed Light Therapy SystemVE2000 PRO0032025-10-30
06970453270326Fractional CO2 Laser Therapy SystemFG900-S2025-10-30
06970453270333Fractional CO2 Laser Therapy SystemFG900-S22025-10-30
06970453270647Diode Laser Therapy MachineFG2000-D+ 2025-10-30
06970453270067Diode Laser Therapy MachineFG 20002022-08-30
06970453270074Diode Laser Therapy MachineFG 2000-B2022-08-30
06970453270081Diode Laser Therapy MachineFG 2000-C2022-08-30
06970453270098Diode Laser Therapy MachineFG 2000-D2022-08-30
06970453270159Picosecond Laser SystemPS10-A2022-10-31
06970453270166Picosecond Laser SystemPS10-B2022-10-31

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