Data / Medical devices / United States / Arch Therapeutics
Arch Therapeutics: FDA-registered device maker in Framingham, MA, United States, 1 510(k) clearance
Arch Therapeutics is registered with the FDA (registration 3013521734) in Framingham, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013521734
- Address
- 235 Walnut Street Suite #6, Framingham, MA, United States, 01702
- Owner or operator
- Arch Therapeutics (10054518)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- March 28, 2017
- Registered through
- 2026
- Brand names listed
- AC5 Advanced Wound System, VIA Linx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer, Manufacturer, 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 11, 2020 | K190129 | AC5 Topical Gel | FRO | Substantially Equivalent | Arch Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Dressing, Wound, Drug
Updated March 11, 2020. 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.