What is FDA product code LIX?

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Cardiovascular › TherapeuticAid, Cardiopulmonary Resuscitation

Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5

Name: Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5
Brand: Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5

Catalogue number XELAED002A, listed by Zoll Medical Corporation, United States, under Aid, Cardiopulmonary Resuscitation. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LIX
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

Record

Regulatory record for Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5
Listed by	Zoll Medical Corporation, United States
FDA product code	LIX
Device type	Aid, Cardiopulmonary Resuscitation
Device class	Class 2
Regulation	21 CFR 870.5210
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2017-02-14
Record revised	2026-02-10 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature -30 to 65 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 0 to 50 °C; Handling environment humidity 10 to 95 % RH
Distribution end date	2026-01-01

Catalogue Numbers

Catalogue numbers for Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5
Catalogue number	Size	Status
XELAED002A		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pocketcpr	Zoll Medical Corporation	3
Moore Medical	Moore Medical Corp.	2
TrueCPR™ Coaching Device	Physio-Control, Inc.	2
CPRmeter 2 (Multi-bundle)	Laerdal Medical Corp.	1
CPRmeter	Laerdal Medical Corp.	1
Onestep Pediaric CPR Multi-Function Electrode, SIN	Zoll Medical Corporation	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K112660	2012-05-10

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.