LifeSync Corporation
Coral Springs, FL, US
LifeSync Corporation appears in FDA device records in Coral Springs, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to LifeSync Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- GMP Companies/Lifesync Corporationrecall
510(k) clearance history
FDA records hold 1 510(k) clearance for LifeSync Corporation in 2007.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1063285 | 1000403400 | LifeSync Corporation | 11705 Nw 39th St, Coral Springs, FL 33065 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GXZElectrode, Needle
- IKTElectrode, Needle, Diagnostic Electromyograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DQAOximeter
- IXOSynchronizer, Ecg / Respirator, Radiographic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1660-2008 | LS-202 Large LeadWear Combo 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 monitors of various manufacturers' systems that have been validated for compatibility. | 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, intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been | Terminated | ||
| Z-1659-2008 | 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 monitors of various manufacturers' systems that have been validated for compatibility. | 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. | Terminated | ||
| Z-0546-2007 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain