Definition: Pain Relief Heat Patches For Temporary Relief Of Muscular And Joint Pian Assoiciated With Arthritis, Simple Backache, Muscle Strains And Sprains.External Use Only. Not On Damaged Skin Or Open Sores. Do No Use Under The Age Of 12. Do Use On People Who
| Device Type ID | 5235 |
| Device Name | Adhesive Backed Thermal Skin Patches |
| Physical State | MFR Must Identify If There Are Any Iron Or Metal Components Or Filings To Avoid Incompatibility With MRI. See March 2009 CDER Advisory On Metal Backed Patches And MRI. Not For Face Or Head. |
| Technical Method | Heat Patches Provide Portable Heat, Are Non-medicated. Heat Is Air-activated. Provides Up To 8 Hours Of Continous Warmth. Patches Are Designed To Stay In Place All Day. |
| Target Area | Use Over Site Of Pain On Any External Body Part With The Exception Of Face Or Head. |
| 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 | OMW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5235 |
| Device | Adhesive Backed Thermal Skin Patches |
| Product Code | OMW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hot Or Cold Disposable Pack. |
| CFR Regulation Number | 890.5710 [🔎] |