Data / Medical devices / United States / FKA Distributing Co., LLC
FKA Distributing Co., LLC: FDA-registered device maker in Riverside, CA, United States, 22 510(k) clearances
FKA Distributing Co., LLC is registered with the FDA (registration 3016452327) in Riverside, CA, United States. It lists 13 device types. The FDA files 22 510(k) clearances under its listings, the newest dated December 22, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016452327
- Address
- 12215 Holly St. --, Riverside, CA, United States, 92509
- Owner or operator
- FKA Brands (1832894)
- Roles
- Repackager or relabeler
- First device listed
- March 8, 2004
- Registered through
- 2026
- Brand names listed
- HoMedics, HoMedics Bubble Bliss Elite Footbath, Homedics, ObusForme
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 |
|---|---|---|---|---|---|---|
| December 22, 2022 | K222949 | Air Compression Leg Massager (Model: LY-670D) | IRP | Substantially Equivalent | Zhejiang Luyao Electronics Technology Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K221862 | YY-A02-B Overlapped Compression Therapy | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
| September 8, 2021 | K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 12, 2020 | K200521 | Full Automatic(NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| November 27, 2019 | K191673 | Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Famidoc Technology Company Limited | accessdata.fda.gov |
| September 16, 2019 | K190507 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| May 22, 2019 | K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | DXQ | Substantially Equivalent | Wenzhou Renhua Instruments Co., Ltd. | accessdata.fda.gov |
| April 3, 2019 | K182597 | Infrared thermometer | FLL | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| July 6, 2016 | K160557 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 14, 2016 | K161156 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 13, 2016 | K160145 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| January 7, 2016 | K153214 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| February 7, 2014 | K130723 | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL | NGX | Substantially Equivalent | Famidoc Technology Co., Ltd. | accessdata.fda.gov |
| June 19, 2013 | K130564 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 18, 2013 | K130563 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 22, 2012 | K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| January 18, 2012 | K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| March 25, 2010 | K093831 | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| February 16, 2010 | K093824 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 31, 2005 | K050491 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| March 30, 2005 | K050249 | HL168JP | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Massager, Therapeutic, Electric
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Stethoscope, Manual
- All makers of Blood Pressure Cuff
Updated December 22, 2022. 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.