# K213313: Veinoflow SCD (Model: LBTK-M-I 5006)

- Pathway: 510(k) (Traditional)
- Applicant: Dalian Labtek Science & Development Co., Ltd.
- Decided: Feb 9, 2022 after 128 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
Longest line of descent: 4 generations back to K953648 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123830: Intermittent Pneumatic Compression Device, Dalian Labtek Science & Development Co., Ltd. (2013) Summary page 5.

## Indications for use
Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.

Source page: https://510kreport.com/device/K213313
Methodology: https://510kreport.com/methodology