Aircast Venaflow Elite System
FDA 510(k) K130722 · Djo, LLC
510(k) numberK130722
Submission
- Device name
- Aircast Venaflow Elite System
- Applicant
- Djo, LLC
Vista, CA, US - Received
- March 18, 2013
- Decision date
- June 20, 2013
- 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
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| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
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| K153224 | VitalStim(R) Plus Electrotherapy SystemIPF · Traditional | 02/17/2016SE |
| K143551 | Compex Wireless USANGX · Traditional | 04/28/2015SE |
| K132284 | Vectra Neo Clinical Therapy SystemIPF · Traditional | 04/10/2014SE |
| K124016 | Empi PhoenixIPF · Abbreviated | 05/06/2013SE |
| K122499 | Aircast Venaflow Elite SystemJOW · Traditional | 10/18/2012SE |
Questions and answers
When was Aircast Venaflow Elite System cleared by the FDA?
Aircast Venaflow Elite System (K130722) received a 510(k) decision of Substantially Equivalent on June 20, 2013, 94 days after the submission was received.
What is the product code of K130722?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.