| Device Type ID | 5088 |
| Device Name | Pack, Hot Or Cold, Disposable |
| 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) Exempt |
| CFR Regulation Number | 890.5710 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IMD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5088 |
| Device | Pack, Hot Or Cold, Disposable |
| Product Code | IMD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hot Or Cold Disposable Pack. |
| CFR Regulation Number | 890.5710 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RAPID AID CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 21 |
Improper Or Incorrect Procedure Or Method | 16 |
Device Operates Differently Than Expected | 12 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Product Quality Problem | 8 |
Temperature Problem | 7 |
Appropriate Term/Code Not Available | 6 |
Device Issue | 4 |
Patient-Device Incompatibility | 3 |
Burst Container Or Vessel | 2 |
Unexpected Therapeutic Results | 2 |
Use Of Device Problem | 2 |
Insufficient Heating | 2 |
Occlusion Within Device | 1 |
Device Dislodged Or Dislocated | 1 |
Physical Property Issue | 1 |
Difficult To Remove | 1 |
Human-Device Interface Problem | 1 |
Leak / Splash | 1 |
Break | 1 |
Charred | 1 |
Overheating Of Device | 1 |
Inadequate User Interface | 1 |
Thermal Decomposition Of Device | 1 |
Material Rupture | 1 |
| Total Device Problems | 108 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | Apr-07-2015 |
| 2 | CooperSurgical, Inc. | II | Mar-19-2015 |
| 3 | Pfizer Inc. | II | Dec-05-2018 |
| 4 | Philips Electronics North America Corporation | II | Apr-04-2016 |
| 5 | Philips Electronics North America Corporation | II | Dec-24-2015 |