| Device Type ID | 5089 |
| Device Name | Pack, Hot Or Cold, Reusable |
| Regulation Description | Cold 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) Exempt |
| CFR Regulation Number | 890.5700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IME |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5089 |
| Device | Pack, Hot Or Cold, Reusable |
| Product Code | IME |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cold Pack. |
| CFR Regulation Number | 890.5700 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Overheating Of Device | 4 |
Fire | 3 |
Physical Property Issue | 2 |
Temperature Problem | 2 |
Leak / Splash | 2 |
Device Handling Problem | 2 |
Human Factors Issue | 1 |
Thermal Decomposition Of Device | 1 |
Use Of Device Problem | 1 |
Device Operates Differently Than Expected | 1 |
Excessive Cooling | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 29 |