FDA Registration
Active
🇨🇳 China
SHENZHEN AINENGKE ELECTRONICS CO, LTD
Reg #: 3033858988
·
FEI: 3033858988
·
Expires 2026
Products
8
Proprietary Names
12
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- SHENZHEN AINENGKE ELECTRONICS CO, LTD
- Registration Number
- 3033858988
- FEI Number
- 3033858988
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building B, 5th Floor, Jinshenghui Technology Park, No. 3, Dafu Industrial Zone, Dafu Community, Guanlan Subdistrict, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K903298
Owner / Operator
- Firm Name
- SHENZHEN AINENGKE ELECTRONICS CO, LTD
- Operator Number
- 10091785
- Address
- Building B, 5th Floor, Jinshenghui Technology Park, No. 3, Dafu Industrial Zone, Dafu Community, Guanlan Subdistrict, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518110
- Country
- CN
- Correspondent
- xiaoguang guo
US Agent
- Business Name
- SOUTH BAY INNOVATION LLC
- Contact Name
- Yueting Zhu
- Address
- 23545 Crenshaw Blvd Ste 106
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
- [email protected]
- Phone
- 424 3769142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2025-08-29 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2025-03-25 |
| Powered Tongue Scraper | QIA | Class 1 | Dental | No | 2026-04-22 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2025-03-25 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2025-03-25 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2026-04-03 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-11-01 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2024-11-01 |
Proprietary Names
Curwy Moon Electric Teeth Cleaner
RELACS 7000, Plaque remover for teeth, Tartar Remover for Teeth, Teeth Cleaning Kit, 5 Modes with 3 tips, with LED Light
Jacquette Scaler
Household Tooth Polisher: X1Pro, X2Pro, X3Pro, X4Pro, X5Pro, X6Pro, X7Pro, X8Pro, X9Pro, X10Pro, X11Pro, X12Pro
Dental mirro
scraper
Breathing Exercise,Deep Breathing Device For Adult Lung Trainer Breathing Exerciser Lung Respiratory Device 5000ml Volum
electric teeth cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9
household dental cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9
Breathing Exercise Device For Lungs,5000ml VolumeMeasurement With Flow Rate Indicator.
electric teeth cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9;
Flat head, pointed end; toothbrush,powerd: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9
Establishment Types
Manufacture Medical Device