| Device Type ID | 5076 |
| Device Name | Pack, Hot Or Cold, Water Circulating |
| Regulation Description | Water Circulating Hot Or 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 | 890.5720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ILO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5076 |
| Device | Pack, Hot Or Cold, Water Circulating |
| Product Code | ILO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Water Circulating Hot Or Cold Pack. |
| CFR Regulation Number | 890.5720 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 20 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Insufficient Information | 5 |
Break | 4 |
Scratched Material | 4 |
Housing | 3 |
Improper Flow Or Infusion | 3 |
Leak / Splash | 3 |
Sparking | 2 |
Device Operates Differently Than Expected | 2 |
Fracture | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Electronic Property Issue | 1 |
Device Displays Incorrect Message | 1 |
Pad | 1 |
Use Of Device Problem | 1 |
Electrical Shorting | 1 |
Plug | 1 |
Hole In Material | 1 |
Noise, Audible | 1 |
Crack | 1 |
Overheating Of Device | 1 |
Insufficient Flow Or Under Infusion | 1 |
Difficult Or Delayed Activation | 1 |
| Total Device Problems | 67 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cincinnati Sub-Zero Products Inc | II | Feb-19-2015 |
| 2 | DeRoyal Industries Inc | II | Jan-27-2014 |
| 3 | Stryker Medical Division Of Stryker Corporation | III | Mar-14-2018 |