Data / Medical devices / China / Chongqing Sonmol Technology Co., Ltd.
Chongqing Sonmol Technology Co., Ltd.: FDA-registered device maker in Chongqing, China, 3 510(k) clearances
Chongqing Sonmol Technology Co., Ltd. is registered with the FDA (registration 3021235837) in Chongqing, China. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 31, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021235837
- Address
- No. 19 Ruihe Road, Shuitu Subdistrict, Liangjiang New Area, Chongqing, China, 400799
- Owner or operator
- Chongqing Sonmol Technology Co., Ltd. (10083174)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 31, 2021
- Registered through
- 2026
- Brand names listed
- EPMDI, Breath-Actuated Pressurized Metered-Dose Inhaler, THE SMARTASSISTANT, UMEP-A1, Handheld steam inhaler, Nasal Aspirator, Nasal Irrigator, Nasal Rinse Salt Package, Nasal Irrigator, Peak Flow Meter, Respiratory Muscle Trainer, Respiratory muscle trainer with manometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Percussor, Powered-Electric | BYI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Nebulizer, Manual | EPN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 31, 2024 | K241338 | Peak Flow Meter | BZH | Substantially Equivalent | Chongqing Moffy Innovation Technology Co., Ltd. | accessdata.fda.gov |
| December 18, 2024 | K240959 | Respiratory Muscle Trainer | BYI | Substantially Equivalent | Chongqing Moffy Innovation Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2021 | K203196 | Peak flow meter | BZH | Substantially Equivalent | Shanghai Sonmol Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Percussor, Powered-Electric
- All makers of Meter, Peak Flow, Spirometry
- All makers of Irrigator, Sinus
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Irrigator, Powered Nasal
Updated December 31, 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.