FDA Registration
Active
🇺🇸 United States
LEAD-LOK, INC. d.b.a Nissha Medical Technologies
Reg #: 3023164
·
FEI: 3023164
·
Expires 2026
Products
8
Proprietary Names
19
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- LEAD-LOK, INC. d.b.a Nissha Medical Technologies
- Registration Number
- 3023164
- FEI Number
- 3023164
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 814 AIRPORT WAY
- City
- Sandpoint
- State
- ID
- ZIP
- 83864
- Country
- US
Owner / Operator
- Firm Name
- Nissha Medical Technologies
- Operator Number
- 9106359
- Address
- 400 EXCHANGE STREET, --
- City
- Buffalo
- State
- NY
- Postal Code
- 14204
- Country
- US
- Correspondent
- Jessica Potter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2023-06-28 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-01-21 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2018-08-23 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2018-08-23 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2012-12-07 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2015-12-18 |
| Amplitude-Integrated Electroencephalograph | OMA | Class 2 | Neurology | No | 2023-08-14 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2023-08-14 |
Proprietary Names
Swaromed
Z-Brand
SofTouch
SilveRest
VersaTrode
Lead-Lok
BluFlex
V-Series
EMS Electrodes
TenderTrode Plus
PhysioFlow
PNS Electrodes
ClearScan
Guardian
Performance Plus
TenderTrode
Regal
SimplySnap
Preventice cardiac monitoring
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)