FDA Registration
Active
🇺🇸 United States
ETEKCITY CORPORATION
Reg #: 3012840029
·
FEI: 3012840029
·
Expires 2026
Products
9
Proprietary Names
21
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ETEKCITY CORPORATION
- Registration Number
- 3012840029
- FEI Number
- 3012840029
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1202 N Miller St Suite A
- City
- Anaheim
- State
- CA
- ZIP
- 92806
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221913
Owner / Operator
- Firm Name
- VESYNC (US) CORPORATION
- Operator Number
- 10053778
- Address
- 1775 Flight Way, Suite 150
- City
- Tustin
- State
- CA
- Postal Code
- 92782
- Country
- US
- Correspondent
- Arthur Sun
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 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-04-18 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2019-04-16 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2023-01-13 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2019-09-11 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2019-09-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-06-17 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2017-01-11 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2022-10-27 |
Proprietary Names
Upper Arm Blood Pressure Monitor, EBP-UA5
K5 Pro
Etekcity TENS Unit ETU-134
Oral Irrigation - ETEKCITY Water Flosser, EWF-32
ETEKCITY TENS Unit Electrodes, ETU-P12
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
EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591S-XXXX
Etekcity Fitness Scale, ESF93, FIT 8S,ESF00, ESF00+,ESF17, ESF18, ESF24, ESF28, ESF37, ESF14, ESF38,ESF-551
System, Measurement, Blood-Pressure, Non-Invasive - Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW
Etekcity Non-Contact Infrared Body Thermometer, HTD8816C
JXB-182 Non-contact Infrared Thermometer
Etekcity Massager, EM-SH7, EM-SH7W, EM-SN8, EM-SN8W, EM-SN8S
Scalp mini 2
S1336HA
EM-SF3
Neck Massager Heated Pro,ENM-C221-WUS,ENM-C221-AUS
Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5
ETB-C031-KUS
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
Establishment Types
Complaint File Establishment per 21 CFR 820.198