FDA Registration
Active
🇺🇸 United States
INBODY BWA, INC.
Reg #: 3027717071
·
FEI: 3027717071
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- INBODY BWA, INC.
- Registration Number
- 3027717071
- FEI Number
- 3027717071
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2550 Eisenhower Avenue, Suite C209
- City
- Trooper
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131064
Owner / Operator
- Firm Name
- InBody BWA, Inc.
- Operator Number
- 10088864
- Address
- 2550 Eisenhower Avenue, Suite C209
- City
- Trooper
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Joongwon Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-03-19 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2025-03-19 |
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2025-03-19 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2025-03-19 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2025-03-19 |
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2025-03-19 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2025-03-19 |
| Ataxiagraph | GWW | Class 1 | Neurology | No | 2025-03-19 |
Proprietary Names
BPBIO 320 S; BPBIO 320 SN; BPBIO 330 S; BPBIO 330 SN; BPBIO 750; BPBIO320; BPBIO320n; BPBIO680KV; BPBIO780KV
Scale
BWA2; BWA2S; InBody270S; InBody380; InBody580; InBody770S; InBody970; InBody970S; InBodyBAND2; Yscope
IB-LS
InBody 120; InBody 120R; InBody 370; InBody 370S; InBody 520; InBody 720
BWA 2; BWA ON; InBody 230; InBody 270
InBody 380; InBody 470; InBody 570; InBody 580
InBody 770; InBody 970; InBody H20(B); InBody M20; InBody S10
InBody230; InBody270; Inbody470; InBody570; InBody770
Disposable Cuff Barrier
FRA 510S
Establishment Types
Complaint File Establishment per 21 CFR 820.198