Data / Medical devices / Dermal Cooling Pack/Vacuum/Massager
Dermal Cooling Pack/Vacuum/Massager (OOK): 16 FDA-registered makers in 8 countries
16 establishments in 8 countries are registered with the FDA to make Dermal Cooling Pack/Vacuum/Massager (product code OOK, Class 2, 21 CFR 878.4340). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on September 12, 2024, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OOK
- Device class
- 2
- Regulation
- 878.4340
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 3 |
| Costa Rica | 1 |
| Germany | 1 |
| Ireland | 1 |
| Thailand | 1 |
| Switzerland | 1 |
| Mexico | 1 |
Makers of Dermal Cooling Pack/Vacuum/Massager
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Allergan | La Aurora De Heredia, Costa Rica | Manufacturer | 1 | September 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shandong Moonlight Electronics Tech Co.,Ltd. | Weifang Shandong, China | Manufacturer | 1 | November 1, 2017 | 0 | 0 | 0 | api.fda.gov |
| AbbVie Deutschland GmbH & Co.KG | Ludwigshafen Rhineland-Palatinate, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AbbVie Ireland NL B.V. Ballytivnan | Sligo, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Automatic Enterprise (Thailand) Co., Ltd. | Rayong, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baitella AG | Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coastline de Mexico SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 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 September 12, 2024. 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.