Data / Medical devices / United States / Etekcity Corporation
Etekcity Corporation: FDA-registered device maker in Anaheim, CA, United States, 8 510(k) clearances
Etekcity Corporation is registered with the FDA (registration 3012840029) in Anaheim, CA, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012840029
- Address
- 1202 N Miller St Suite A, Anaheim, CA, United States, 92806
- Owner or operator
- VESYNC (US) CORPORATION (10053778)
- Roles
- Complaint file establishment
- First device listed
- January 11, 2017
- Registered through
- 2026
- Brand names listed
- EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591S-XXXX, EFS-C651-KUS,EFS-C651-KJP, EFS-C651-KDE, EFS-C651-KUK, EFS-C651-XXXX, EFS-E661-WUS,EFS-E661-KUS,EFS-E661-PUS,EFS-E661-XXXX,EFS-C671-WUST,EFS-C671-WUS, EM-SF3, ETB-C011-KUS, ETB-C011-WUS, ETB-C011-BUS, ETB-C011-YUS, ETB-C011-PUS, ETB-C013-KUS, ETB-C013-WUS, ETB-C013-BUS,, ETB-C013-PUS, ETB-C013-YUS, ETB-C013-GUS, DYS-C01R5, ETB-C031-KUS, ETEKCITY TENS Unit Electrodes, ETU-P12 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | 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 |
|---|---|---|---|---|---|---|
| October 12, 2022 | K221913 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| October 4, 2021 | K200558 | Smart Neck Stimulator | NUH | Substantially Equivalent | Guandong Skg Intelligent Technology Co., Ltd. | accessdata.fda.gov |
| November 13, 2019 | K191570 | Infrared Thermometer Model MD-H30 | FLL | Substantially Equivalent | Guangzhou Berrcom Medical Device Co., Ltd. | accessdata.fda.gov |
| January 3, 2019 | K180435 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical (Shenzhen), Inc. | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| November 14, 2014 | K141076 | GARMENT ELECTRODES | GXY | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| September 16, 2013 | K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) | NUH | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Massager, Therapeutic, Electric
- All makers of Irrigator, Powered Nasal
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated October 12, 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.