| Device Type ID | 5170 |
| Device Name | Pad, Heating, Powered |
| Regulation Description | Powered Heating Pad. |
| 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 | 890.5740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IRT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5170 |
| Device | Pad, Heating, Powered |
| Product Code | IRT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Heating Pad. |
| CFR Regulation Number | 890.5740 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AVACEN INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIGITAL HEAT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Heater | 39 |
Adverse Event Without Identified Device Or Use Problem | 34 |
Improper Or Incorrect Procedure Or Method | 8 |
Use Of Device Problem | 4 |
Fire | 3 |
Device Inoperable | 2 |
Device Operates Differently Than Expected | 1 |
Device Component Or Accessory | 1 |
Melted | 1 |
Smoking | 1 |
Temperature Problem | 1 |
Thermal Decomposition Of Device | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 97 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 2k Innovations Inc. | II | Apr-12-2017 |
| 2 | Battle Creek Equipment Co. | II | Nov-03-2016 |
| 3 | Ergoactives, Llc | II | Jul-07-2016 |