FDA.reportPublic FDA data

NeoControl

Primary DI
00864618000308
Brand
NeoControl
Company
MAGIC RACE LLC
Model
N-0228-F-220VAC
Device description
Control Unit, 220 volt, NeoControl Pelvic Floor Therapy System
Published
2017-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864618000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864618000308008646180003088646180003080864618000308

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(498) 934-1040info@kitalpha-med.de

Regulatory Flags#

DUNS number
080456235
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864618000315NeoControlN-0228-G-110VAC2017-01-08
00864618000322NeoControlN-0227-A2017-01-08
00864618000339NeoToneN-0243-B-220VAC2017-01-08
00864618000346NeoToneN-0243-B-110VAC2017-01-08
00864618000353NeoToneN-0242-B2017-01-08
00864618000360NeoToneN-0242-T2017-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
G680LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
03830054237728StarFormerFOTONA d.o.o.KPI2024-07-30
00092237626047Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
00092237626054Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
06970935830482KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830499KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830642KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830659KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830666KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830673KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830680KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830697KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16
00860000860000Yarlap IRelevium Labs, Inc.KPI2023-10-07
00860000860031Yarlap IIRelevium Labs, Inc.KPI2023-10-07
05033435070039TensCareTENSCARE LIMITEDKPI2023-08-31
04719871189108iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-30
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25