Artassist and Venassist
FDA 510(k) K131146 · Aci Medical, LLC
510(k) numberK131146
Submission
- Device name
- Artassist and Venassist
- Applicant
- Aci Medical, LLC
San Marcos, CA, US - Received
- April 23, 2013
- Decision date
- February 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
More from Manamed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K942530 | Art-Assist Model AA-1000JOW · Traditional | 02/28/1996SE |
| K903894 | Venapulse Models VP-25 and VP-50JOW · Traditional | 04/03/1991SE |
| K903532 | Unna-Sleeve(Tm)LLK · Traditional | 11/02/1990SE |
| K881291 | Air Plethysmograph Model APG-1000DSB · Traditional | 10/14/1988SE |
| K861645 | Micro-Tracheostomy Care KitBTO · Traditional | 05/09/1986SE |
| K844309 | IV RatemeterFLN · Traditional | 01/22/1985SE |
Questions and answers
When was Artassist and Venassist cleared by the FDA?
Artassist and Venassist (K131146) received a 510(k) decision of Substantially Equivalent on February 10, 2014, 293 days after the submission was received.
What is the product code of K131146?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.