Data / Medical devices / United States / Makromed, Inc.
Makromed, Inc.: FDA-registered device maker in Salem, NH, United States, 1 510(k) clearance
Makromed, Inc. is registered with the FDA (registration 3029464335) in Salem, NH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029464335
- Address
- 88 Stiles Road, Salem, NH, United States, 03079
- Owner or operator
- Makromed, Inc. (10088725)
- Roles
- Complaint file establishment
- First device listed
- October 5, 2023
- Registered through
- 2026
- Brand names listed
- Ultimate rTMS, Yingchi rTMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcranial Magnetic Stimulator | OBP | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 13, 2023 | K230735 | Ultimate rTMS; Yingchi rTMS | OBP | Substantially Equivalent | Brain Ultimate, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2023. 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.