| Device Type ID | 211 |
| Device Name | Trousers, Anti-shock |
| Regulation Description | Compressible Limb Sleeve. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LHX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 211 |
| Device | Trousers, Anti-shock |
| Product Code | LHX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Compressible Limb Sleeve. |
| CFR Regulation Number | 870.5800 [🔎] |
| Device Problems | |
|---|---|
Break | 29 |
Loose Or Intermittent Connection | 5 |
Device Damaged Prior To Use | 4 |
Component Missing | 4 |
Appropriate Term/Code Not Available | 2 |
Device Inoperable | 1 |
Difficult To Remove | 1 |
Naturally Worn | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 48 |