Data / Medical devices / United States / Diode Art Engineering Dba Air Relax
Diode Art Engineering Dba Air Relax: FDA-registered device maker in City Industry, CA, United States, 3 510(k) clearances
Diode Art Engineering Dba Air Relax is registered with the FDA (registration 3011413020) in City Industry, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated September 2, 2021. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011413020
- Address
- 347 South Stimson Avenue Unit A09, City Industry, CA, United States, 91744
- Owner or operator
- DIODE ART ENGINEERING DBA AIR RELAX (10048725)
- Roles
- Complaint file establishment
- First device listed
- June 17, 2021
- Registered through
- 2026
- Brand names listed
- AIR RELAX MODEL AR-1 & MODEL AR-2, AIR RELAX PLUS MODEL AR-3, AIR RELAX PRO MODEL AR-4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 2021 | K212491 | Air Relax Pro Model AR-4.0 | IRP | Substantially Equivalent | Diode Art Engineering Doing Business AS Air Relax | accessdata.fda.gov |
| May 25, 2021 | K211460 | Air Relax Plus Model AR-3.0 | IRP | Substantially Equivalent | Diode Art Engineering Doing Business AS Air Relax | accessdata.fda.gov |
| March 5, 2021 | K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | IRP | Substantially Equivalent | Maxstar Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 2, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.