Data / Medical devices / United States / Anzen Health
Anzen Health: FDA-registered device maker in Chicago, IL, United States, 1 510(k) clearance
Anzen Health is registered with the FDA (registration 3017235663) in Chicago, IL, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 24, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017235663
- Address
- 4245 N. Knox Ave. #801, Chicago, IL, United States, 60641
- Owner or operator
- Anzen Health (10078168)
- Roles
- Specification developer
- First device listed
- January 12, 2024
- Registered through
- 2026
- Brand names listed
- AIZOME Healthcare Bedding, AIZOME Healthcare Towels, AIZOME Healthwear, Disposable Cap, Disposable Isolation Gown, Disposable Medical Face Mask, Disposable Shoe Cover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Surgical | FYF | 1 | Specification developer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Specification developer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Specification developer | accessdata.fda.gov |
| Mattress And Bed Deck Cover (Medical Purposes) | QTV | 1 | Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 24, 2019 | K182514 | Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Mask, Surgical
- All makers of Mattress And Bed Deck Cover (Medical Purposes)
- All makers of Cover, Shoe, Operating-Room
- All makers of Cap, Surgical
- All makers of Dress, Surgical
Updated January 24, 2019. 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.