# K241746: Umed Reprocessed Aircast Venaflow Foot Cuff; Umed Reprocessed Kendall SCD Express Sleeve; Umed Reprocessed Aircast Elite Calf Cuff 3040 3050; Umed Reprocessed CTC VP 501 Calf Cuff; Umed Reprocessed CTC VP 520 Foot Cuff

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Resources, LLC
- Decided: Oct 4, 2024 after 108 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 I 3050 is used in the s11me manner邸intended by the original device m叩ufacturer (OEM) lo incre邸e venous blood flow in at-risk patients in order to prevent deep vein thrombosis(DVT) and. The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home. The UMED REPROCESSED AffiCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis(DVD. The device is a prescription device for the use in a clinical setting or in the home.

Source page: https://510kreport.com/device/K241746
Methodology: https://510kreport.com/methodology
