Shenzhen Homed Medical Device Co Ltd
Shenzhen city Guangdong, CN
SHENZHEN HOMED MEDICAL DEVICE CO LTD appears in FDA device records in Shenzhen city Guangdong, CN. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Shenzhen Homed Medical Device Co Ltd between 2017 and 2025. The busiest year on record is 2017, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252616 | Portable oxygen concentrator (JLO-190P) | CAW | Substantially Equivalent | |
| K212395 | Nebulizer | CAF | Substantially Equivalent | |
| K170886 | HOMED Mesh Nebulizer | CAF | Substantially Equivalent | |
| K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | CAF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010287621 | 3010287621 | SHENZHEN HOMED MEDICAL DEVICE CO LTD | Room 1601-1614, A Building , Jinxiu III, No.85 Hudi Pai, Shenzhen city Guangdong 518109 CN | 2026 | and 3 more, listed in full below |
| 3013000203 | 3013000203 | SHENZHEN HOMED MEDICAL DEVICE CO LTD | Block 5, 2 Anyue Road, Chashan Town,Dongguan City 523393, Guangdong Province, People's Republic of China, Dongguan Guangdong 523393 CN | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- CATCannula, Nasal, Oxygen
- BTICompressor, Air, Portable
- CAWGenerator, Oxygen, Portable
- BYGMask, Oxygen
- BYPMouthpiece, Breathing
- KCONasal Spray, Ent Delivery
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- BZOSet, Tubing And Support, Ventilator (W Harness)
- JOWSleeve, Limb, Compressible
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- JRLUnit, Filter, Membrane
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain