FDA.reportPublic FDA data

ActivaTek Ionto4 Kit

Primary DI
20768627016296
Brand
ActivaTek Ionto4 Kit
Company
NORTH COAST MEDICAL, INC.
Model
NC89376
Catalog number
4511
Device description
ActivaTek Ionto4 Kit MD (12)
Published
2025-04-02
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20768627016296PackageGS150In Commercial Distribution
10768627016299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2076862701629620768627016296
1076862701629910768627016299

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality electrotherapy systemAn assembly of nonimplantable devices intended to apply multiple electrotherapy modalities [e.g., transcutaneous electrical nerve stimulation (TENS), galvanic stimulation, medicinal electrophoresis (iontophoresis), interferential current] to various parts of the body for the treatment of multiple types of conditions (e.g., gynaecological, proctological, dermatological, neurological, dental and ENT). It consists of an electrically-powered control unit/generator and a handpiece with dedicated applicators/probes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4087765000custserve@ncmedical.com

Regulatory Flags#

DUNS number
060121928
Device count
1
DM exempt
true
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
true
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
00768627017145Blue Diamond 360 Needle Stimulator4581NCBD-3602026-06-01
00768627017152Blue Diamond 360 Needle Stimulator Lead Wires - Alligator Clip4581NCBD-360-012026-06-01
00768627017169Blue Diamond 360 Needle Stimulator Lead Wires - Pigtail4581NCBD-360-022026-06-01
00768627017275Norco Sharps Container4595NC229412026-06-01
00768627017282Norco Nitrile Gloves4594NC20545-12026-06-01
00768627017299Norco Nitrile Gloves4594NC20545-122026-06-01
00768627017305Norco Nitrile Gloves4594NC20545-32026-06-01
00768627017312Norco Nitrile Gloves4594NC20545-42026-06-01
10768627016497Push Patch Controlled Released 12.04549NC881912025-12-01
00768627016995PushPatch Delicate (6)4549NC881922025-12-01
00768627016988PushPatch Delicate (6)4549NC881922025-12-01
20768627016494Push Patch Controlled Released 12.04549NC881912025-12-01
10768627016299ActivaTek Ionto4 KitNC8937645112025-04-02
10768627016305ActivaTek Ionto4 KitNC8937745112025-04-02
10768627016312ActivaTek Ionto4 ButterflyNC8937845112025-04-02
10768627016282ActivaTek Ionto4 KitNC8937545112025-04-02
20768627016302ActivaTek Ionto4 KitNC8937745112025-04-02
20768627016319ActivaTek Ionto4 ButterflyNC8937845112025-04-02
00768627001632NorcoNC8948141232025-03-26
00768627160285Blue DiamondNCBD-161343082023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02
00850030915085Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02