Product Code: LHX FDA class 2 21 CFR 870.5800

Trousers, Anti-Shock

Cardiovascular

Anti-shock trousers, also known as pneumatic anti-shock garments (PASG) or military anti-shock trousers (MAST), are inflatable garments applied to the lower extremities and abdomen to apply pressure and counteract circulatory shock by redistributing blood volume toward the core and vital organs in emergency or trauma settings. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LHX and is regulated under 21 CFR 870.5800 within the Cardiovascular specialty. No special flags apply to this device.

510(k)s
4
FEI Numbers
1
Registration Numbers
1
Unique Applicants
4
Years Active
14

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Basic Information

Product Code
LHX
Device Class
FDA class 2
Regulation Number
870.5800
Medical Specialty
Cardiovascular
Review Panel
CV
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K953763 GLADIATOR ANTISHOCK PANTS
K874774 TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
K841605 BP TRAUMA AIR PANTS
K812564 ZEE LIFE SUPPORT AIR PANTS

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.