Data / Medical devices / Electrode, Circular (Spiral), Scalp And Applicator
Electrode, Circular (Spiral), Scalp And Applicator (HGP): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Electrode, Circular (Spiral), Scalp And Applicator (product code HGP, Class 2, 21 CFR 884.2675). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on January 17, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HGP
- Device class
- 2
- Regulation
- 884.2675
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Sweden | 2 |
| Finland | 1 |
| Canada | 1 |
| United Kingdom | 1 |
| Costa Rica | 1 |
| Lebanon | 1 |
Makers of Electrode, Circular (Spiral), Scalp And Applicator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Complaint file establishment, Specification developer | 1 | February 11, 1980 | 0 | 0 | 0 | api.fda.gov |
| Cetro America | Meriden, CT, United States | Specification developer | 1 | July 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Clinical Innovations, LLC | Murray, UT, United States | Complaint file establishment, Manufacturer | 1 | September 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Chicopee, MA, United States | Manufacturer | 1 | January 29, 1991 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | January 29, 1991 | 0 | 0 | 0 | api.fda.gov |
| Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | GANANOQUE Ontario, Canada | Manufacturer | 1 | January 29, 1991 | 0 | 0 | 0 | api.fda.gov |
| Neoventa Medical AB | Molndal Vastra Gotaland, Sweden | Specification developer | 1 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Rocket Medical Plc | WASHINGTON Sunderland, United Kingdom | Manufacturer, Repackager or relabeler | 1 | May 1, 1985 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cetro Medical AB | Smalandsstenar Jonkoping, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lebanese International Technologies | MAZRAET YACHOUH Liban-Nord, Lebanon | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 17, 2025. 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.