Data / Medical devices / United States / Arche Healthcare
Arche Healthcare: FDA-registered device maker in Pound Ridge, NY, United States, 1 510(k) clearance
Arche Healthcare is registered with the FDA (registration 3003771601) in Pound Ridge, NY, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 24, 2008. Registered through 2026. FDA data exported November 3, 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
- 3003771601
- Address
- 23 Split Rock Road, Pound Ridge, NY, United States, 10576
- Owner or operator
- Arche Healthcare (10025074)
- Roles
- Repackager or relabeler
- First device listed
- March 12, 2008
- Registered through
- 2026
- Brand names listed
- Bailey Monofilament, DermaStat, PressureStat, TempStat, VibraTip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Esthesiometer | GXB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Foot Examination Tool For Inflammatory Changes | OIZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Pressure Measurement, Intermittent | JFC | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 24, 2008 | K080816 | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT | OIZ | Substantially Equivalent | Visual Footcare Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Hygiene
- All makers of System, Pressure Measurement, Intermittent
- All makers of Esthesiometer
- All makers of Foot Examination Tool For Inflammatory Changes
- All makers of Fork, Tuning
Updated June 24, 2008. 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.