# K020211: Body Force, Model BT 6000

- Pathway: 510(k) (Traditional)
- Applicant: Composites Solutions, Inc.
- Decided: Jun 28, 2002 after 157 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zoex Antishock Trousers: named in the summary without a submission number

## Indications for use
The BODY FORCE is a medical device used on patients who have experienced an abdomirlaV pelvic crush injury- The purpose is ta prevent a decrease in the central blood volume during transportation to a trauma center. Indications for use are: (Tourniquet) 1) Uncontrollable hemorrhaging in the leg(s)

Source page: https://510kreport.com/device/K020211
Methodology: https://510kreport.com/methodology