Cpr Aid Device Without Feedback
The CPR Aid Device Without Feedback (product code PMK) is a Class 1 cardiovascular device designed for professionally trained CPR rescuers, performing simple functions such as proper hand placement and prompting for compression rate and timing without providing quality feedback, regulated under 870.5210. Class 1 devices are subject to general controls only and may be exempt from 510(k) requirements. The device is not an implant and is not life-sustaining.
Research product code PMK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PMK
- Device Class
- FDA class 1
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
Definition
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.