TrueCPR™ Coaching Device
TrueCPR is a chest-compression coaching device that measures chest movement and provides real-time feedback during CPR. Its chest pad and back pad form a sensing pair, with one pad above…
TrueCPR is a chest-compression coaching device that measures chest movement and provides real-time feedback during CPR. Its chest pad and back pad form a sensing pair, with one pad above and the other beneath the patient. The filed item is the multilingual Config B package.
The device measures the changing distance between the pads using electromagnetic signals. This design measures compression depth relative to the back pad, rather than relying only on movement at the chest surface.
Listed Item
Truecpr,packaged,multi-Language, Config B
Feedback Display
The screen represents compression depth with a moving indicator and shows separate target zones for depth and recoil. A metronome can provide timing prompts, while the display gives the rescuer feedback about compression movement.
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.
| 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
| Listed by | Physio-Control, Inc., United States |
|---|---|
| FDA product code | LIX |
| Device type | Aid, Cardiopulmonary Resuscitation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5210 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-11-11 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80596 | In distribution | |
| 80596 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pocketcpr | Zoll Medical Corporation | 3 |
| Moore Medical | Moore Medical Corp. | 2 |
| Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5 | Zoll Medical Corporation | 1 |
| 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
| Clearance | Decision date |
|---|---|
| K123597 | 2013-04-17 |
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.