Data / Medical devices / United States / Blue Poppy Enterprises
Blue Poppy Enterprises: FDA-registered device maker in Portland, OR, United States, 1 510(k) clearance
Blue Poppy Enterprises is registered with the FDA (registration 1000587715) in Portland, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000587715
- FEI number
- 1000125602
- Address
- 4804 Se 69TH Ave, Portland, OR, United States, 97206
- Owner or operator
- Blue Poppy Enterprises (10072710)
- Roles
- Specification developer
- First device listed
- April 30, 2020
- Registered through
- 2026
- Brand names listed
- BALANCE, TEMPO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 2 | 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 |
|---|---|---|---|---|---|---|
| July 15, 2015 | K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | MQX | Substantially Equivalent | Maanshan Bond Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 15, 2015. 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.