Portable oxygen concentrator (JLO-190P)— 510(k) K252616
Substantially EquivalentShenzhen Homed Medical Device Co., Ltd.
FDA 510(k) clearance K252616 for Portable oxygen concentrator (JLO-190P), Substantially Equivalent on 2025-12-22. Applicant: Shenzhen Homed Medical Device Co., Ltd..
Clearance details
- Applicant
- Shenzhen Homed Medical Device Co., Ltd.
- Product code
- Code CAW
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.