Data / Medical devices / China / Shenzhen Homed Medical Device Co Ltd
Shenzhen Homed Medical Device Co Ltd: FDA-registered device maker in Shenzhen city Guangdong, China, 5 510(k) clearances
Shenzhen Homed Medical Device Co Ltd is registered with the FDA (registration 3010287621) in Shenzhen city Guangdong, China. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 25, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010287621
- Address
- Room 1601-1614, A Building, Jinxiu III, No.85 Hudi Pai Songxuan Community, Guanhu Street, Longhua District, Shenzhen city Guangdong, China, 518109
- Owner or operator
- Shenzhen Homed Medical Device Co., Ltd (10041952)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- September 23, 2012
- Registered through
- 2026
- Brand names listed
- APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, BYX - TUBING, PRESSURE AND ACCESSORIES, Compressor Nebulizer, Curelief Purabreathe Mesh Nebulizer, MASK, OXYGEN, MOUTHPIECE, BREATHING, Nebulizer, SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Specification developer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Specification developer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Specification developer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Specification developer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Specification developer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Specification developer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Specification developer | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 25, 2022 | K212395 | Nebulizer | CAF | Substantially Equivalent | Shenzhen Homed Medical Device Co., Ltd. | accessdata.fda.gov |
| June 21, 2018 | K170886 | HOMED Mesh Nebulizer | CAF | Substantially Equivalent | Shenzhen Homed Medical Device Co., Ltd. | accessdata.fda.gov |
| September 6, 2017 | K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | CAF | Substantially Equivalent | Shenzhen Homed Medical Device Co., Ltd. | accessdata.fda.gov |
| June 30, 2015 | K150591 | Besmed Reusable Jet Nebulizer | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| June 28, 2002 | K020932 | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR | CAF | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Tubing, Noninvasive
- All makers of Cannula, Nasal, Oxygen
- All makers of Unit, Filter, Membrane
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated March 25, 2022. 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.