| Device Type ID | 5223 |
| Device Name | Infant Heel Warmer (chemical Heat Pack) |
| Regulation Description | Hot Or Cold Disposable Pack. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5710 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MPO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5223 |
| Device | Infant Heel Warmer (chemical Heat Pack) |
| Product Code | MPO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hot Or Cold Disposable Pack. |
| CFR Regulation Number | 890.5710 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOPERSURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RAPID AID CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Burst Container Or Vessel | 11 |
Material Integrity Problem | 2 |
Leak / Splash | 2 |
Fluid Leak | 2 |
Material Perforation | 1 |
Crack | 1 |
Hole In Material | 1 |
Explosion | 1 |
| Total Device Problems | 21 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Jul-20-2015 |
| 2 | Covidien LLC | II | Aug-21-2015 |