FDA product code PMJ: Cpr Aid Feedback Device (No Software)
PMJ is the FDA product code for cpr aid feedback device (no software). It is a Class II device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel. Devices under PMJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines
Classification
| Field | Value |
|---|---|
| Device name | Cpr Aid Feedback Device (No Software) |
| Device class | Class II |
| Regulation | 21 CFR 870.5210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for PMJ devices
openFDA lists no recalls for product code PMJ.
Frequently asked questions
What is FDA product code PMJ?
PMJ is the FDA product code for cpr aid feedback device (no software). It is a Class II device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel.
What device class is PMJ?
Class II, regulation 21 CFR 870.5210. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PMJ
- Run a recall and safety report across every PMJ manufacturer
- Watch product code PMJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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