Modification to the Grip
FDA 510(k) K010526 · Elcare Innovations, Inc.
510(k) numberK010526
Submission
- Device name
- Modification to the Grip
- Applicant
- Elcare Innovations, Inc.
Burleson, TX, US - Received
- February 22, 2001
- Decision date
- December 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIX – Aid, Cardiopulmonary Resuscitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5210
- Specialty
- Cardiovascular
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
Other 510(k)s with product code LIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201581 | CPR BandLIX · Traditional | Credo | 03/06/2021SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | Laerdal Medical AS | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | Laerdal Medical AS | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | Laerdal Medical AS | 08/13/2015SE |
| K123248 | CPR RSQ AssistLIX · Traditional | Avantech, Inc. | 12/10/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | Physio-Control, Inc. | 04/17/2013SE |
| K122050 | Cprmeter CPR Feedback DeviceLIX · Traditional | Laerdal Medical A/S | 10/22/2012SE |
| K112660 | PocketcprLIX · Abbreviated | Zoll Medical Corp | 05/10/2012SE |
| K092408 | Rhythm of Life, Model R0901-05LIX · Traditional | Rapid Response Solutions, LLC | 10/14/2009SE |
| K071321 | PocketcprLIX · Traditional | Bio-Detek, Inc. | 09/12/2007SE |
Questions and answers
When was Modification to the Grip cleared by the FDA?
Modification to the Grip (K010526) received a 510(k) decision of Substantially Equivalent on December 13, 2001, 294 days after the submission was received.
What is the product code of K010526?
The FDA product code is LIX – Aid, Cardiopulmonary Resuscitation, a Class II (moderate risk) device regulated under 21 CFR 870.5210.