Definition: Intended To Move Excess Fluid From The Target Area To Another Area Of The Body.
| Device Type ID | 977 |
| Device Name | Sleeve, Head And Neck, Compressible |
| Physical State | The Device Consists Of Fabric Garments, Which May Be Filled With Air Chambers, That Are Designed To Wrap Around The Head, Face, And/or Neck And Apply Compression. The Garments May Be Attached To A Controller, Which Manages Inflation/deflation Of Air |
| Technical Method | Uses Compression Of The Target Area To Move Excess Fluid To Another Area Of The Body |
| Target Area | Head, Face And/or Neck |
| Regulation Description | Compressible Limb Sleeve. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PPS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 977 |
| Device | Sleeve, Head And Neck, Compressible |
| Product Code | PPS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Compressible Limb Sleeve. |
| CFR Regulation Number | 870.5800 [🔎] |