Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063285

FEI Number

1000403400

Entity Name

LifeSync Corporation

City/State/Country

Coral Springs, FL, US

Establishment Address

11705 Nw 39th St, Coral Springs, FL 33065, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

LifeSync Corporation (Owner Number: 10023616)

Owner / Operator Contact Address

11705 NW 39th Street, Coral Springs, FL 33065, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172981

PMA Number

N/A

All Registered Proprietary Names

Rochester Rochester ABI Rochester 3 Lead Yoke Mate LWS, GE Multi-Link 5 Lead YokeMate LWS, GE Multi-Link/Datex Pristine 5 Lead Reusable MX40 Cable to PHILIPS, 10ft, AHA 5 Lead YokeMate LWS GE Apex Pro FH ABI Rochester GoldSelect UltraPoint ABI Vital Connections STEALTHSHIELD LifeSync YokeMate LWS AMC Cables

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-02-15
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2023-01-26
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2023-01-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-11
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-04-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-01-26
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2019-04-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-03-25
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2021-09-01
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-12

Official Correspondent

Renee Pierre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LifeSync Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063285. Last updated year: 2026. Please use registration number 1063285 when referencing this establishment in official correspondence.