Data / Medical devices / United States / Ergonomic Products, Inc.
Ergonomic Products, Inc.: FDA-registered device maker in Fall River, MA, United States, 1 510(k) clearance
Ergonomic Products, Inc. is registered with the FDA (registration 3004064895) in Fall River, MA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 18, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004064895
- Address
- 198 Airport Rd, Fall River, MA, United States, 02720
- Owner or operator
- Ergonomic Products, Inc. (10046842)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 20, 2014
- Registered through
- 2027
- Brand names listed
- Aurora, Ergonomic Products 3 Series Dental Chair, Ergonomic Products Workstation, FastTrack
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 18, 2014 | K132315 | ERGONOMIC PRODUCTS WORKSTATION | EIA | Substantially Equivalent | Ergonomic Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of Light, Operating, Dental
Updated April 18, 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.