Panels › Cardiovascular › Product code JOW · Class 2
Sleeve, Limb, Compressible
Regulation 870.5800
8510(k)s in 12 months (354 all time)
0recalls in 12 months (32 all time)
30recalls that name a 510(k)
Top companies in JOW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2025 | Cardinal Health 200, LLC Kendall SCD Blended Comfort
Sleeves Knee Length Small -
For use with Kendall SCD
SmartFlow
SKU 84021B
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| Jun 6, 2025 | Cardinal Health 200, LLC Kendall SCD Comfort Sleeves
Knee Length Small, Pediatric -
For use with Kendall SCD
SmartFlow, SKU 84021P
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| Jun 6, 2025 | Cardinal Health 200, LLC SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| May 19, 2023 | Stryker Sustainability Solutions REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile Open, Classified |
JOW | K100909 |
| Jul 9, 2021 | Ortho8, Inc. EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile Open, Classified |
JOW | None listed |
| Jul 9, 2021 | Ortho8, Inc. CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free, Open, Classified |
JOW | None listed |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S Terminated |
JOW | K974393 |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S Terminated |
JOW | K974393 |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S Terminated |
JOW | K974393 |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S Terminated |
JOW | K974393 |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S Terminated |
JOW | K974393 |
| Apr 8, 2019 | Compass Health Brands (Corporate Office) MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S Terminated |
JOW | K974393 |
| Feb 15, 2019 | COVIDIEN LLC Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 Terminated |
JOW | K781357 |
| Jan 17, 2019 | DJO, LLC Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. Open, Classified |
JOW | K964238 |
| Dec 1, 2017 | Stryker Sustainability Solutions 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector.
Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and Terminated |
JOW | K012403 |
| Jun 26, 2017 | Arjo, Inc. dba ArjoHuntleigh ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099
Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribe Terminated |
JOW | K143438 |
| Jul 3, 2013 | DJO, LLC VenaFlow Elite 30B-B and 30BI-B
Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis. Terminated |
JOW | K091700 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Calf Garment Standard Ref. L501-M Lot 122549, 122985
- Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546
- Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570
- SCD Express Compres Terminated |
JOW | K012658 |
| Feb 20, 2013 | Stryker Sustainability Solutions STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor). Terminated |
JOW | K090308 |
| Dec 27, 2012 | Arjo, Inc. dba ArjoHuntleigh Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence Terminated |
JOW | K010744 |
| Jan 11, 2012 | Medical Compression Systems ActiveCare DVT
Medical Compression Systems
OR Aqiva, IL
Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound Terminated |
JOW | K023573 |
| Jan 11, 2012 | Medical Compression Systems ActiveCare +SFT
Medical Compression Systems
OR Aqiva, IL
Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing woun Terminated |
JOW | K060146 |
| Nov 14, 2011 | Albahealth LLC Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC.
Prevention of DVT. Terminated |
JOW | K961405 |
| Oct 1, 2010 | Covidien LP AVI Sterile Impad Rigid Sole Foot Cover, Left Foot
Product Code:6067 Terminated |
JOW | K951683 |
| Oct 1, 2010 | Covidien LP AVI Sterile Impad Rigid Sole Foot Cover, Right Foot
Product Code:6066 Terminated |
JOW | K951683 |
| Jan 13, 2009 | Sterilmed Inc Compression Sleeves
Model #'s:
HUNDVT10-1 and
KEN5329
The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is a Terminated |
JOW | K003857 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K051438 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. Terminated |
JOW | K012403 |
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