Data / Medical devices / Dermal Cooling Pack/Vacuum/Massager / United States
FDA-registered makers of Dermal Cooling Pack/Vacuum/Massager in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Dermal Cooling Pack/Vacuum/Massager (product code OOK). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Dermal Cooling Pack/Vacuum/Massager
- Product code
- OOK
- Country
- United States
Makers of Dermal Cooling Pack/Vacuum/Massager in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Zeltiq Aesthetics, Inc. | Pleasanton, CA, United States | Complaint file establishment, Specification developer | 13 | September 12, 2024 | 0 | 2 | 0 | api.fda.gov |
| Zeltiq Aesthetics Inc. | Dublin, CA, United States | Manufacturer | 12 | September 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zeltiq Aesthetics Inc | Dublin, CA, United States | Manufacturer | 6 | September 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zeltiq Aesthetics, Inc. | Livermore, CA, United States | Manufacturer | 4 | September 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Silgan Unicep Packaging, LLC. | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silgan Unicep Packaging, LLC. | Spokane, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Shelf Manufacturing, LLC | Tracy, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.