Data / Medical devices / United States / Golden Needle Acupuncture Herbal & Medical Supply, Inc.
Golden Needle Acupuncture Herbal & Medical Supply, Inc.: FDA-registered device maker in Fletcher, NC, United States, 4 510(k) clearances
Golden Needle Acupuncture Herbal & Medical Supply, Inc. is registered with the FDA (registration 3007391546) in Fletcher, NC, United States. It lists 1 device type. The FDA files 4 510(k) clearances 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
- 3007391546
- Address
- 2 Rutledge Circle, Fletcher, NC, United States, 28732
- Owner or operator
- Golden Needle Acupuncture Herbal & Medical Supply, Inc. (10028667)
- Roles
- Complaint file establishment
- First device listed
- March 5, 2025
- Registered through
- 2026
- Brand names listed
- AcuFast, Alpha, EACU, alpha
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 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 |
|---|---|---|---|---|---|---|
| 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 |
| December 2, 2013 | K132896 | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE | MQX | Substantially Equivalent | Asia-Med GmbH and CO KG | accessdata.fda.gov |
| November 22, 2006 | K061517 | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Prime Herbs Corporation | accessdata.fda.gov |
| May 4, 1999 | K990328 | DBC, DONG BANG ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Morning Star, Dong Bang Acupuncture U.S.A., Inc. | 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.