Data / Medical devices / Scalp Cooling System
Scalp Cooling System (PMC): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Scalp Cooling System (product code PMC, Class 2, 21 CFR 878.4360). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on November 25, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PMC
- Device class
- 2
- Regulation
- 878.4360
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Sweden | 1 |
| United Kingdom | 1 |
| India | 1 |
| Mexico | 1 |
Makers of Scalp Cooling System
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 |
|---|---|---|---|---|---|---|---|---|
| Dignitana AB | Lund Skane, Sweden | Specification developer | 2 | June 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Paxman Coolers Limited | Fenay Bridge, Huddersfield Kirklees, United Kingdom | Manufacturer | 2 | June 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cooler Heads Care, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Dignitana, Inc. | Dallas, TX, United States | Specification developer | 1 | June 26, 2019 | 0 | 1 | 0 | api.fda.gov |
| Stemtech Medical Devices Private Limited | Navi Mumbai Maharashtra, India | Manufacturer | 1 | November 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermotek, Inc. | Flower Mound, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 25, 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.