Data / Medical devices / Macau / Etekcity Company Limited
Etekcity Company Limited: FDA-registered device maker in Macau, Macau, 5 510(k) clearances
Etekcity Company Limited is registered with the FDA (registration 3017887928) in Macau, Macau. It lists 9 device types. The FDA files 5 510(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
- 3017887928
- Address
- L 7/F, China Plaza, Da Ma Road, South Bay, Macau, Macau, 999078
- Owner or operator
- ETEKCITY COMPANY LIMITED (10079727)
- Roles
- Exporter to the US
- First device listed
- December 21, 2020
- Registered through
- 2026
- Brand names listed
- EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591SXXXX, 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, 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, ETEKCITY TENS Unit Electrodes, ETU-P12, Etekcity Fitness Scale, ESF93, FIT 8S, ESF00, ESF00+, ESF17, ESF18, ESF24, ESF28, ESF37, ESF14, ESF38, ESF-551, Etekcity Massager, EM-SF3,S1336HA,Scalp mini 2,K5 Pro, Etekcity Massager, EM-SH7, EM-SH7W, EM-SN8, EM-SN8W, EM-SN8S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Exporter to the US | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Exporter to the US | 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 |
| 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 |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Irrigator, Powered Nasal
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Massager, Therapeutic, Electric
- All makers of Electrode, Cutaneous
- All makers of Analyzer, Body Composition, Exempt
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.