FDA Registration
Active
🇰🇷 South Korea
InBody Factory #2,
Reg #: 3022764531
·
FEI: 3022764531
·
Expires 2026
Products
4
Proprietary Names
20
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- InBody Factory #2,
- Registration Number
- 3022764531
- FEI Number
- 3022764531
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 330, Yeongok-gil, Ipjang-myueon, Seoubuk-gu,
- City
- Cheonan-si Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K200442
Owner / Operator
- Firm Name
- InBody Co. Ltd.
- Operator Number
- 9041413
- Address
- 15, Heugam-gil, Ipjang-myueon, Seoubuk-gu,
- City
- Cheonan-si,
- State
- Chungnam
- Postal Code
- 31025
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2020-06-10 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-12-04 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2021-01-06 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2010-11-08 |
Proprietary Names
Scale
BP170B
BPBIO250
BP160B
BP170
BP160
BPBIO220T
BPBIO210T
BPBIO210
BPBIO220
BPBIO320n
BPBIO320
BPBIO680KV
BPBIO 320 S
BPBIO780KV
BPBIO 320 SN
BPBIO 330 S
BPBIO 330 SN
BPBIO 750
BPBIO750
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device