Data / Medical devices / United States / Loh Enterprises, LLC
Loh Enterprises, LLC: FDA-registered device maker in Clarks Summit, PA, United States, 2 510(k) clearances
Loh Enterprises, LLC is registered with the FDA (registration 3006160539) in Clarks Summit, PA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006160539
- Address
- 318 Davis Street, Clarks Summit, PA, United States, 18411
- Owner or operator
- Loh Enterprises, LLC (10079642)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 11, 2021
- Registered through
- 2026
- Brand names listed
- Coyote, CoyoteR, CoyoteSteel, CoyoteT, CoyoteA, Felix, Loh Medical, PA0009
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Positioning, Electric | INO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 18, 2021 | K202482 | Y207 Electric Wheelchair | ITI | Substantially Equivalent | Jiangsu Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| October 5, 2005 | K052468 | YK9000 SERIES MANUAL WHEELCHAIR | IOR | Substantially Equivalent | Intco Metal Products (Zhenjiang) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Mechanical
- All makers of Chair, Positioning, Electric
- All makers of Tips And Pads, Cane, Crutch And Walker
- All makers of Wheelchair, Powered
Updated March 18, 2021. 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.