FDA Registration
Active
🇰🇷 South Korea
STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING
Reg #: 3011562129
·
FEI: 3011562129
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
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
- K190924
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, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2020-11-23 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-11-23 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2020-11-23 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2020-11-23 |
Proprietary Names
STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING
STIMULATOR ELECTRICAL TRANSCUTANEOUS FOR ARTHRITIS
STIMULATOR NERVE TRANSCUTANEOUS OVER THE COUNTER
STIMULATOR MUSCLE POWERED
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)