FDA Registration
Active
🇲🇴 Macao
ETEKCITY COMPANY LIMITED
Reg #: 3017887928
·
FEI: 3017887928
·
Expires 2026
Products
9
Proprietary Names
15
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- ETEKCITY COMPANY LIMITED
- Registration Number
- 3017887928
- FEI Number
- 3017887928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- L 7/F, China Plaza, 762-804 Da Ma Road, South Bay,
- City
- Macau
- Country
- MO
Regulatory Submissions
- 510(k) Number
- K221913
Owner / Operator
- Firm Name
- ETEKCITY COMPANY LIMITED
- Operator Number
- 10079727
- Address
- L 7/F, China Plaza, 762-804 Da Ma Road, South Bay,
- City
- Macau
- State
- MO-NOTA
- Postal Code
- 999078
- Country
- MO
- Correspondent
- Wayne Pan
US Agent
- Business Name
- ATEKCITY CORPORATION
- Contact Name
- Wayne Pan
- Address
- 174 W Lincoln Ave Pmb 589
- City
- Anaheim
- State
- CA
- ZIP
- 92805
- Country
- US
- [email protected]
- Phone
- 515 7822647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-01-15 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2021-05-20 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2023-01-13 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2022-10-27 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-05-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-12-21 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2021-05-10 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-05-20 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-05-20 |
Proprietary Names
Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW
Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5
Etekcity Massager, EM-SF3,S1336HA,Scalp mini 2,K5 Pro
Etekcity Massager, EM-SH7, EM-SH7W, EM-SN8, EM-SN8W, EM-SN8S
IRRIGATOR, POWERED NASAL
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
JXB-182 Non-contact Infrared Thermometer
Etekcity Non-Contact Infrared Body Thermometer, HTD8816C
Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5
EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591SXXXX
EFS-E661-WUS,EFS-E661-KUS,EFS-E661-PUS,EFS-E661-XXXX,EFS-C671-WUST,EFS-C671-WUS
EFS-C651-KUS, EFS-C651-KJP, EFS-C651-KDE, EFS-C651-KUK, EFS-C651-XXXX
Etekcity Fitness Scale, ESF93, FIT 8S, ESF00, ESF00+, ESF17, ESF18, ESF24, ESF28, ESF37, ESF14, ESF38, ESF-551
Etekcity TENS Unit ETU-134
Establishment Types
Export Device to the United States But Perform No Other Operation on Device