Definition: Intended To Provide Pressure To The Soleus Muscle For The Purpose Of Temporarily Reducing Lower Back Pain That Radiates Down The Leg Associated With Normal Household Or Work Activities.
| Device Type ID | 5243 |
| Device Name | Orthosis, Limb, For Back Pain |
| Physical State | The Device Is A Leg Wrap With A Pressure Pad. |
| Technical Method | The Device Is Worn Around The Calf Of One Leg And Includes A Pad To Exert Pressure Against The Soleus Muscle. |
| Target Area | Soleus Muscle Behind The Lower Limb. |
| Regulation Description | Limb Orthosis. |
| 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 | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PMV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5243 |
| Device | Orthosis, Limb, For Back Pain |
| Product Code | PMV |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NATURES PILLOWS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |