Data / Medical devices / Pump, Nebulizer, Manual
Pump, Nebulizer, Manual (EPN): 20 FDA-registered makers in 6 countries
20 establishments in 6 countries are registered with the FDA to make Pump, Nebulizer, Manual (product code EPN, Class 1, 21 CFR 874.5220). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 30, 1989, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EPN
- Device class
- 1
- Regulation
- 874.5220
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 7 |
| India | 1 |
| France | 1 |
| Vietnam | 1 |
| Pakistan | 1 |
Makers of Pump, Nebulizer, Manual
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 |
|---|---|---|---|---|---|---|---|---|
| Accumedix, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Better Medical Technology Co., Ltd. | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Sinoshine Technology Co.,ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Rongrui-Century Science&technology Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Feellife Health Inc. | Shenzhen Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kli Corp. | Carmel, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mada Medical Products, Inc. | Carlstadt, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MG Developpement | mauguio Herault, France | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MG Development America Inc. | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Fly Medical Devices Co., Ltd. | Minhang District Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Wanbo Technology Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bona Pharma Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinoshine Health Technology Co., Ltd | Tan Uyen City Binh Duong, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solid Toys Ind. Ltd. | Boluo County, Huizhou,City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesla Biohealing, Inc. | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tian Medical Inc | Libertyville, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| University Medical Devices | Omaha, NE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 30, 1989. 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.