FDA.reportPublic FDA data

Insulating Waterproof ePTFE Pouch

Primary DI
00860013508647
Brand
Insulating Waterproof ePTFE Pouch
Company
General Vibronics, LLC
Model
GV-EPTFE-01
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K242553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242553000MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.2024-11-21PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013508647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013508647008600135086478600135086470860013508647

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment system generatorA component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020484227
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013508609MIRARI Cold Plasma unit box setGVM2-012025-04-30
00860013508616MIRARI Cold Plasma DriverGVM22025-04-30
00860013508623MIRARI Cold Plasma System Insulating Fleece PouchGV-FL-012025-04-30
00860013508630MIRARI Cold Plasma System ArrayGVPA-10BB2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
08034108513263body ESTIQDEKA M.E.L.A. SRLPBX2025-09-26
07290016746785V-FC Pro FullVIORA LTDPBX2025-09-01
07290016746808V-FC Pro TipVIORA LTDPBX2025-09-01
07290016746815V-FC Pro HandpieceVIORA LTDPBX2025-09-01
05391540830857Préime DermaFacial EMA AESTHETICS LIMITEDPBX2025-08-07
08800099100146Hi-TENSWINBACK GO EASTPBX2025-07-23
08800099100016BACK4Winback Go East Co., Ltd.PBX2025-07-16
08800099100023BACK3TXWinback Go East Co., Ltd.PBX2025-07-16
08800016905083Wav12CLASSYS Inc.PBX2025-07-02
08800016905106Wav50CLASSYS Inc.PBX2025-07-02
08800016905175QUADESSY Wavplus hand pieceCLASSYS Inc.PBX2025-07-02
D650WONDER1Wonder Touch XOD Inc.PBX2025-07-01
08800092099010TENSAMAX PRO+Daeyang Medical Co., Ltd.PBX2025-06-20
07290016746464V-ST Single Use tipVIORA LTDPBX2025-06-03
07290016746471V-VR HandpieceVIORA LTDPBX2025-06-03
17290016746652V-FC TipVIORA LTDPBX2025-05-22
00860013508609MIRARI Cold Plasma unit box setGeneral Vibronics, LLCPBX2025-04-30
00860013508616MIRARI Cold Plasma DriverGeneral Vibronics, LLCPBX2025-04-30
00860013508623MIRARI Cold Plasma System Insulating Fleece PouchGeneral Vibronics, LLCPBX2025-04-30