Data / Medical devices / United States / Calmare Therapeutics Incorporated
Calmare Therapeutics Incorporated: FDA-registered device maker in Shelton, CT, United States, 1 510(k) clearance
Calmare Therapeutics Incorporated is registered with the FDA (registration 3006435903) in Shelton, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 20, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006435903
- Address
- 2 Trap Falls Rd Suite 507, Shelton, CT, United States, 06484
- Owner or operator
- Calmare Therapeutics Incorporated (10028870)
- Roles
- Manufacturer
- First device listed
- March 13, 2009
- Registered through
- 2026
- Brand names listed
- Calmare(R) Pain Therapy Device, model PMT-1, MC-5a, PMT-1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | 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 |
|---|---|---|---|---|---|---|
| February 20, 2009 | K081255 | SCRAMBLER ST 5 TENS DEVICE | GZJ | Substantially Equivalent | Competitive Technologies,Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 20, 2009. 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.