Data / Medical devices / United States / LifeSync Corporation
LifeSync Corporation: FDA-registered device maker in Coral Springs, FL, United States, 15 510(k) clearances
LifeSync Corporation is registered with the FDA (registration 1063285) in Coral Springs, FL, United States. It lists 12 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 8, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1063285
- FEI number
- 1000403400
- Address
- 11705 Nw 39th St, Coral Springs, FL, United States, 33065
- Owner or operator
- LifeSync Corporation (10023616)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- 3 Lead Yoke Mate LWS, GE Multi-Link, 5 Lead Disposable MX40 to Pinch, Shld, 29", AHA, SPO2, 5 Lead Reusable MX40 Cable to PHILIPS, 10ft, AHA, 5 Lead YokeMate LWS GE Apex Pro FH, 5 Lead YokeMate LWS, GE Multi-Link/Datex Pristine, ABI, AMC Cables, Advantage Blood Pressure Cuff and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2018 | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| April 24, 2017 | K170536 | ECG Disposable Lead Wire | DSA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| June 3, 2015 | K142159 | DISPOSABLE PRE-GELLED SURFACE ELECTRODE | GXY | Substantially Equivalent | Rochester Electro Medical, Inc. | accessdata.fda.gov |
| April 3, 2009 | K082846 | APK SPO2 PULSE OXIMETER SENSOR | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| July 15, 2008 | K080914 | ULTRASHARP CONCENTRIC NEEDLES | IKT | Substantially Equivalent | Rochester Electro Medical, Inc. | accessdata.fda.gov |
| October 19, 2007 | K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | GXY | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| March 20, 2007 | K063863 | ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER | DXQ | Substantially Equivalent | Advantage Medical Cables, Inc. | accessdata.fda.gov |
| August 5, 2003 | K030795 | LIFESYNE SYSTEMS | DRG | Substantially Equivalent | Gmp/Companies, Inc. | accessdata.fda.gov |
| March 1, 2000 | K992524 | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES | DSA | Substantially Equivalent | Advantage Medical Electronics, Inc. | accessdata.fda.gov |
| May 27, 1999 | K990015 | ELECTRODE NEEDLES | IKT | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| September 19, 1997 | K972901 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| August 14, 1997 | K971540 | AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| April 15, 1997 | K970755 | STEALTHSHIELD | DRX | Substantially Equivalent | Vital Connections, Inc. | accessdata.fda.gov |
| October 18, 1995 | K953889 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| March 22, 1988 | K880320 | ELECTRODE CABLE | DSA | Substantially Equivalent | Vital Connections, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 13, 2007 | 47336 | Not yet classified | Terminated | LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG m | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring. | accessdata.fda.gov |
| January 10, 2007 | 37252 | Not yet classified | Terminated | LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 | When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation. | accessdata.fda.gov |
Compare with other makers
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Updated June 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.