# K121106: Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression Gauntlet

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Appliance Industries, Inc.
- Decided: Apr 27, 2012 after 15 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991570 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013852: Jobst Ready-to-Wear Gauntlet, Bsn-Jobst, Inc. (2002) Summary page 1.
- K991570: Jobst Ready-to-Wear Arm Sleeves, Beiersdorf-Jobt, Inc. (1999) Summary page 1.

## Indications for use
The TRUFORMO Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and IsIndicated for use Inthe management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations. The TRUWoRM Ready-To-Wear Compression Gauntlet is Intended to be used to apply pressure tothe hand and wrist and is indicated for use Inthe management of Lymphedema and other edema.

Source page: https://510kreport.com/device/K121106
Methodology: https://510kreport.com/methodology