WINBACK

Primary DI
08800099100146
Brand
WINBACK
Company
WINBACK GO EAST
Model
Hi-TENS
Device description
The Hi-TENS device generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld and active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz. Electrodes are attached with an active cable that plugs in on the lateral side of the unit. A safety switch feature allows the patient to shut down the unit in the event of any discomfort.
Published
2025-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220014000RSHOCKSwims America Corp2023-03-01PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800099100146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800099100146088000991001468800099100146

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy system, professional-useAn assembly of electrically-powered devices designed for professional use to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694959157
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800099100016WINBACKBACK42025-07-16
08800099100023WINBACKBACK3TX2025-07-16

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Primary DI, Brand, Company table
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