Data / Medical devices / United States / Amarigo Inc
Amarigo Inc: FDA-registered device maker in Los Angeles, CA, United States, 5 510(k) clearances
Amarigo Inc is registered with the FDA (registration 3027135885) in Los Angeles, CA, United States. It lists 15 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027135885
- Address
- 1990 S Bundy DR Ste 410, Los Angeles, CA, United States, 90025
- Owner or operator
- AMARIGO INC (10089972)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 28, 2024
- Registered through
- 2026
- Brand names listed
- AOJ-20T,CH-S691L,TMB-2296-BT, Aneroid sphygmomanometer:NT-20, NT-201,NT-50, Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D,AOJ-30E, AOJ-30F and AOJ-30G, Arm Electronic Blood Pressure Monitor(FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112), Blackhead Remover:SL0001-1, Blackhead spatula:GUGU-FS-XK-VO3, BS-357, DT-211A,DT-101,DT-02,NT-01, Dental irrigator AOW01,AOW02,AOW03,AOW04,AOW05,AOW06, AOW07 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 27, 2024 | K241899 | Pelvic Floor Stimulator (Intrelief PFE) | KPI | Substantially Equivalent | Easymed Instruments Co., Ltd. | accessdata.fda.gov |
| September 22, 2023 | K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | ITI | Substantially Equivalent | Yurob Rehabilitation Medical Co., Ltd. | accessdata.fda.gov |
| December 1, 2022 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 31, 2022 | K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| January 2, 2019 | K181215 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
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Updated November 27, 2024. 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.