FDA.reportPublic FDA data

APK

Primary DI
06946725572139
Brand
APK
Company
APK Technology Co.,Ltd.
Model
I-A0002D06
Device description
GE Apex Compatible Disposable ECG Leadwire, 6-lead, AHA, Pinch
Published
2026-10-13
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
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170536000ECG Disposable Lead WireAPK Technology Co., Ltd.2017-04-24DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725572139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725572139069467255721396946725572139

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

Regulatory Flags#

DUNS number
529691989
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
06946725572108APKI-RLW-04BG-51AS-00002026-10-13
06946725572115APKI-A511E-EL12026-10-13
06946725572122APKI-A-CO-205-012026-10-13
06946725500989APKI-RLW-03AK-39AS-00002025-07-22
06946725500996APKI-RLW-03BK-39AS-00002025-07-22
06946725501009APKI-RLW-05AK-39AS-00002025-07-22
06946725501016APKI-RLW-05BK-39AS-00002025-07-22
06946725501030APKI-RLW-05BK-MXAS-00002025-07-22
06946725501047APKI-RLW-05AV-39AS-00002025-07-22
06946725501054APKI-RLW-05BV-39AS-00002025-07-22
06946725501061APKI-RLW-05AU-34AS-00002025-07-22
06946725501078APKI-RLW-05BU-34AS-00002025-07-22
06946725501085APKI-LDW-03AB-29AS-01002025-07-22
06946725501092APKI-RLW-03AB-39AS-00002025-07-22
06946725501108APKI-LDW-03AB-51AS-01002025-07-22
06946725501115APKI-RLW-03AB-63AS-00002025-07-22
06946725501122APKI-LDW-03BB-29AS-01002025-07-22
06946725501139APKI-RLW-03BB-39AS-00002025-07-22
06946725501146APKI-LDW-03BB-51AS-01002025-07-22
06946725501153APKI-RLW-03BB-63AS-00002025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03