COCOON CONVECTIVE WARMING SYSTEM— 510(k) K140635
Substantially EquivalentCare Essentials Pty, Ltd.
FDA 510(k) clearance K140635 for COCOON CONVECTIVE WARMING SYSTEM, Substantially Equivalent on 2014-07-25. Applicant: Care Essentials Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Care Essentials Pty, Ltd.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parkside, South Australia, AU
Recent devices under product code DWJ
view allMore clearances from Care Essentials Pty, Ltd.
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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 →
Recalls naming K140635
K-number listed on FDA's recall record- Z-0986-2020 — Cocoon Convective Warming System, Product Code: CWS4000 (110V).
- Z-0987-2020 — Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140635.
Data sourced from openFDA. This site is unofficial and independent of the FDA.