FDA.reportPublic FDA data

Alpha

Primary DI
00194711116072
Brand
Alpha
Company
Willowwood Global LLC
Model
ACLS-049-X18
Catalog number
ACLS-049-X18
Device description
Alpha Control Liner System Kit Extra Small, 18 cm Leads
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223738000Alpha Control Liner System (ACLS)Coapt2023-01-11GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194711116072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194711116072001947111160721947111160720194711116072

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-848-4930xx@xx.xx

Regulatory Flags#

DUNS number
004280723
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194711121014IntuyWW-1LK-1BWW-1LK-1B2025-03-21
00194711121021IntuyWW-1LK-1WWW-1LK-1W2025-03-21
00194711300006LimbLogicLL-01220LL-012202025-03-21
00194711300013LimbLogicLL-01240LL-012402025-03-21
00194711300082LimbLogicLLV-01030LLV-010302025-03-21
00194711300099LimbLogicLLV-01041LLV-010412025-03-21
00194711300105LimbLogicLLV-01043LLV-010432025-03-21
00194711300112LimbLogicLLV-01044LLV-010442025-03-21
00194711300129LimbLogicLLV-01045LLV-010452025-03-21
00194711300136LimbLogicLLV-01048LLV-010482025-03-21
00194711300143LimbLogicLLV-01049LLV-010492025-03-21
00194711300150LimbLogicLLV-01050LLV-010502025-03-21
00194711300167LimbLogicLLV-01070LLV-010702025-03-21
00194711300174LimbLogicLLV-01071LLV-010712025-03-21
00194711300181LimbLogicLLV-01080LLV-010802025-03-21
00194711300198LimbLogicLLV-01100LLV-011002025-03-21
00194711300204LimbLogicLLV-02002LLV-020022025-03-21
00194711300211LimbLogicLLV-02003LLV-020032025-03-21
00194711300228LimbLogicLLV-02004LLV-020042025-03-21
00194711300235LimbLogicLLV-02005LLV-020052025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02