FDA.reportPublic FDA data

Alpha

Primary DI
00194711116157
Brand
Alpha
Company
Willowwood Global LLC
Model
ACLS-049-S14
Catalog number
ACLS-049-S14
Device description
Alpha Control Liner System Kit Small, 14 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
00194711116157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194711116157001947111161571947111161570194711116157

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
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08