FDA Registration
Active
🇰🇷 South Korea
STIMULATOR ELECTRICAL TRANSCUTANEOUS FOR ARTHRITIS
Reg #: 3011562129
·
FEI: 3011562129
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MIRAE MEDI&TECH CO., LTD.
- Registration Number
- 3011562129
- FEI Number
- 3011562129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22, Baekseokgongdan 5-gil, Seobuk-gu
- City
- Cheonan-si Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K192887
Owner / Operator
- Firm Name
- MIRAE Medi&Tech Co., Ltd.
- Operator Number
- 10049046
- Address
- 22, Baekseokgongdan 5-gil, Seobuk-gu
- City
- Cheonan-si
- State
- Chungnam
- Postal Code
- 331-979
- Country
- KR
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2020-11-23 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2020-11-23 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2020-11-23 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2020-11-23 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-11-23 |
Proprietary Names
STIMULATOR ELECTRICAL TRANSCUTANEOUS FOR ARTHRITIS
STIMULTATOR NERVE TRANSCUTANEOUS OVER THE COUNTER
STIMULATOR MUSCLE POWERED
STIMULATOR NERVE TRANSCUTANEOUS FOR PAIN RELIEF
STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)