FDA Registration
Active
🇺🇸 United States
I-SENS USA, INC.
Reg #: 3008780388
·
FEI: 3008780388
·
Expires 2026
Products
9
Proprietary Names
20
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- I-SENS USA, INC.
- Registration Number
- 3008780388
- FEI Number
- 3008780388
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3545 Lomita Blvd., Unit D
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121133
Owner / Operator
- Firm Name
- i-SENS USA, Inc.
- Operator Number
- 10034826
- Address
- 3545 Lomita Blvd., Unit D
- City
- Torrance
- State
- CA
- Postal Code
- 90505
- Country
- US
- Correspondent
- Jeonghan Ha
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2022-01-10 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2022-01-10 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-01-10 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2022-01-10 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-06-29 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-06-27 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-06-27 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2023-07-11 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-06-27 |
Proprietary Names
CareSens N Voice Blood Glucose Monitoring System
CareSens N Blood Glucose Monitoring System
KetoSens BT Blood B-Ketone Monitoring System
CareSens N Feliz BT Blood Glucose Monitoring System
CareSens N Feliz Blood Glucose Monitoring System
CareSens Pen Needle
CareSens N POP Blood Glucose Monitoring System
Nocoding1 Plus Blood Glucose Monitoring System
CareSens S Fit Blood Glucose Monitoring System
CS Tianjin Lancet Multiple Use
CS Tianjin Lancet Single use
CareSens N Plus BT Blood Glucose Monitoring System
CareSens S Fit BT Blood Glucose Monitoring System
KetoSens Blood B-Ketone Monitoring System
KetoSens Multi Blood B-Ketone Monitoring System
EZFAST Body Fat Analyzer GBF-2108-B
CareSens S Clear BT Blood Glucose Monitoring System
EZFAST Blood Pressure Monitor
CareSens N Premier BT Blood Glucose Monitoring System
CareSens N Premier Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198