TRUECPR COACHING DEVICE
FDA 510(k) clearance K123597 · decided 2013-04-17
Clearance details
- K-number
- K123597
- Device name
- TRUECPR COACHING DEVICE
- Applicant
- Physio-Control, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-21
- Decision date
- 2013-04-17
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- LIX
- Device class
- 2
- Regulation number
- 870.5210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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| CPR RSQ ASSIST (K123248) | Avantech, Inc. | 2013-12-10 |
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| POCKETCPR (K112660) | Zoll Medical Corp | 2012-05-10 |
| RHYTHM OF LIFE, MODEL R0901-05 (K092408) | Rapid Response Solutions, LLC | 2009-10-14 |
| POCKETCPR (K071321) | Bio-Detek, Inc. | 2007-09-12 |
| MODIFICATION TO THE GRIP (K010526) | Elcare Innovations, Inc. | 2001-12-13 |
| CPR EZY MASK AND PAD (K003937) | Medteq Innovations Pty, Ltd. | 2001-06-06 |
| CPR PROMPT (K954692) | County Line , Ltd. | 1996-03-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFEPAK® 35 Defibrillator/monitor (P160026/S063) | Physio-Control, Inc. | 2025-12-04 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S064) | Physio-Control, Inc. | 2025-11-21 |
| LIFEPAK® CR2 Automated External Defibrillator (P170018/S023) | Physio-Control, Inc. | 2025-11-06 |
| LIFEPAK 1000 defibrillator (P160026/S062) | Physio-Control, Inc. | 2025-10-14 |
| LIFEPACK® CR2 Automated External Defibrillator (AED) (P170018/S024) | Physio-Control, Inc. | 2025-09-29 |
| LIFEPAK FLEX Lithium-ion Battery (P160026/S061) | Physio-Control, Inc. | 2025-06-30 |
| LIFEPAK® CR2 Defibrillator (P170018/S022) | Physio-Control, Inc. | 2025-06-20 |
| LIFEPAK 35 monitor/defibrillator (P160026/S059) | Physio-Control, Inc. | 2025-06-20 |