Powerheart® G5 Semi Automatic AED
Powerheart G5 semi-automatic AED is a portable, battery-powered defibrillator for trained responders treating an unresponsive person who is not breathing or not breathing normally. It…
Powerheart G5 semi-automatic AED is a portable, battery-powered defibrillator for trained responders treating an unresponsive person who is not breathing or not breathing normally. It analyzes the heart rhythm through defibrillation pads and determines whether a shock is needed.
Voice and text prompts guide the responder through the rescue. If a shockable rhythm is detected, the semi-automatic device charges and advises the operator to deliver the shock. The pads can remain attached after resuscitation to continue detecting the ECG rhythm.
Listed Item
Powerheart® G5 Semi Automatic AED. Package includes: Powerheart® G5 Semi Automatic AED, battery, set of adult defirillation pads and AED manager
Patient Pads
Adult pads are preconnected. Pediatric defibrillation pads are used for children up to eight years old or up to 25 kilograms. The device performs self-tests.
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Cardiac Science, Inc., United States |
|---|---|
| FDA product code | MKJ |
| Device type | Automated External Defibrillators (Non-Wearable) |
| Device class | Class 3 |
| Regulation | 21 CFR 870.5310 |
| 510(k) | K122758 |
| Record published | 2015-01-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 570 to 1060 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G5S-01P0 | In distribution | |
| G5S-01A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X Series | Zoll Medical Corporation | 862 |
| E Series | Zoll Medical Corporation | 571 |
| M Series | Zoll Medical Corporation | 219 |
| R Series | Zoll Medical Corporation | 216 |
| Lifepak® 15 monitor/defibrillator | Physio-Control, Inc. | 188 |
| AED Plus | Zoll Medical Corporation | 124 |
| Lifepak® 12 defibrillator/monitor | Physio-Control, Inc. | 122 |
| Lifepak CR Plus and Lifepak Express defibrillators | Physio-Control, Inc. | 111 |
| M Series Biphasic | Zoll Medical Corporation | 111 |
| PadPro | ConMed Corporation | 96 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 71 |
| Lifepak® 20 and Lifepak 20e defibrillator/monitors | Physio-Control, Inc. | 59 |
Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143714 | 2015-05-04 |
| K122758 | 2014-02-12 |
| K102496 | 2011-06-09 |
| K091943 | 2009-09-10 |
| K082090 | 2008-12-12 |
| K060934 | 2006-05-15 |
| K052316 | 2006-01-03 |
| K052161 | 2005-10-21 |
| K040637 | 2004-08-06 |
| K040438 | 2004-07-01 |
| K031987 | 2003-07-30 |
| K022929 | 2003-01-27 |
| K022210 | 2002-10-04 |
| K012197 | 2001-11-16 |
| K993533 | 2000-01-24 |
| K982710 | 1998-08-10 |
| K970741 | 1997-10-16 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P160008 | 2026-05-07 | HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories | Heartsine Technologies, Ltd |
| P170018 | 2025-11-06 | LIFEPAK® CR2 Automated External Defibrillator | Physio-Control, Inc. |
| P160032 | 2025-07-03 | Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E | Defibtech, LLC |
| P210015 | 2025-01-29 | Avive Automated External Defibrillator (AED) System | Avive Solutions Inc |
| P200005 | 2024-01-09 | TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | TZ Medical, Inc. |
| P200007 | 2023-06-23 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed |
| P200004 | 2022-06-16 | ConMed PadPro Multifunction Electrodes | ConMed Corporation |
| P160012 | 2021-07-08 | Infant/Child Reduced Energy Defibrillation Electrodes | Physio-Control, Inc. |
| P160033 | 2021-06-14 | Powerheart G5 AED | Zoll Medical Corporation |
| P190013 | 2021-02-02 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | AED Battery Exchange, LLC |
| P180028 | 2020-08-22 | HeartStart FRx Defibrillator | Philips Medical Systems Technologies Ltd |
| P190007 | 2020-08-07 | Cardinal Health Multifunctional Defibrillation Electrode | Cardinalhealth |
| P160022 | 2020-06-11 | X Series and Propaq MD | Zoll Medical Corporation |
| P160015 | 2020-06-05 | AED 3 Defibrillator with Uni-Padz | Zoll Medical Corporation |
| P160028 | 2020-05-11 | Philips HeartStart FR3 Defibrillator | Philips Medical Systems Technologies Ltd |
| P160026 | 2020-02-13 | LIFEPAK Automated External Defibrillators (AEDs) | Physio-Control, Inc. |
| P160034 | 2019-08-20 | Powerheart® G3 Pro AED | Zoll Medical Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.