FDA Registration
Active
🇺🇸 United States
BIOSPACE INC.
Reg #: 3003193933
·
FEI: 3003193933
·
Expires 2026
Products
8
Proprietary Names
43
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- BIOSPACE INC.
- Registration Number
- 3003193933
- FEI Number
- 3003193933
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13850 CERRITOS CORPORATE DR STE C
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130777
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 |
|---|---|---|---|---|---|
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2013-11-27 |
| Ataxiagraph | GWW | Class 1 | Neurology | No | 2021-03-13 |
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2020-06-10 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-04-14 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2010-11-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-09-11 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2020-07-17 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2020-02-25 |
Proprietary Names
InBody370
InBody 720
InBody 520
InBody120
InBody120R
InBody370S
FRA510S
Scale
Disposable Cuff Barrier
BPBIO320n
BPBIO320
BPBIO680KV
BPBIO 320 S
BPBIO780KV
BPBIO 320 SN
BPBIO 330 S
BPBIO 330 SN
BPBIO 750
IB-LS
Yscope
InBody BAND2
InBody970
BWA2
InBody380
InBody970S
InBody770S
InBody580
InBody270S
BWA2S
InBody280
InBody230
InBody570
InBody770G
InBody S10
InBody270
Inbody470
InBody H20B
InBody 470
InBody 270
InBody M20
InBody 770
InBody 230
BWA ON
Establishment Types
Complaint File Establishment per 21 CFR 820.198