Data / Medical devices / United States / Inbody Bwa, Inc.
Inbody Bwa, Inc.: FDA-registered device maker in Trooper, PA, United States, 3 510(k) clearances
Inbody Bwa, Inc. is registered with the FDA (registration 3027717071) in Trooper, PA, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 23, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027717071
- Address
- 2550 Eisenhower Avenue Suite C209, Trooper, PA, United States, 19403
- Owner or operator
- InBody BWA, Inc. (10088864)
- Roles
- Complaint file establishment
- First device listed
- March 19, 2025
- Registered through
- 2026
- Brand names listed
- BPBIO 320 S; BPBIO 320 SN; BPBIO 330 S; BPBIO 330 SN; BPBIO 750; BPBIO320; BPBIO320n; BPBIO680KV; BPBIO780KV, BWA 2; BWA ON; InBody 230; InBody 270, BWA2; BWA2S; InBody270S; InBody380; InBody580; InBody770S; InBody970; InBody970S; InBodyBAND2; Yscope, Disposable Cuff Barrier, FRA 510S, IB-LS, InBody 120; InBody 120R; InBody 370; InBody 370S; InBody 520; InBody 720, InBody 380; InBody 470; InBody 570; InBody 580 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Complaint file establishment | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment | accessdata.fda.gov |
| Ataxiagraph | GWW | 1 | Complaint file establishment | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Complaint file establishment | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Isokinetic Testing And Evaluation | IKK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2014 | K141483 | BIOSPACE BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| November 25, 2013 | K130777 | INBODY | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| September 4, 2013 | K131064 | BIOSPACE | DXN | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
Compare with other makers
- All makers of System, Isokinetic Testing And Evaluation
- All makers of Scale, Patient
- All makers of Analyzer, Body Composition
- All makers of Analyzer, Body Composition, Exempt
- All makers of Platform, Force-Measuring
Updated September 23, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.