# K092391: Mobileaed, Mobileals, Mobileaed+ and Advantageaed

- Pathway: 510(k) (Traditional)
- Applicant: Concord Medical Products
- Decided: Apr 1, 2010 after 239 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic PhysicControl LifePak 500: named in the summary without a submission number
- (no number) Cardiac Science Powerheart G3: named in the summary without a submission number
- (no number) Zoll AED Pro: named in the summary without a submission number
- (no number) Philips Heartstream FR2+: named in the summary without a submission number

## Indications for use
The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device. When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight. The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 lbs (251Kg). The MobileALS and MobileAED+ products are the same as the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users. The rescuer may use the ECG monitoring node cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECC analysis either in background or by pressing the analyze button. Contraindications for Use - Defibrillation Do not use the MobileAED for defibrillation when the patient; Is conscious; or Is breathing; or Has a detectable pulse or other signs of circulation

Source page: https://510kreport.com/device/K092391
Methodology: https://510kreport.com/methodology