OMNI WARM GEL PACKS— 510(k) K936084
Substantially EquivalentOmni Therm, Inc.
FDA 510(k) clearance K936084 for OMNI WARM GEL PACKS, Substantially Equivalent on 1994-03-31. Applicant: Omni Therm, Inc.. Device class: 1.
Clearance details
- Applicant
- Omni Therm, Inc.
- Product code
- Code IMD
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code IMD
view allMore clearances from Omni Therm, Inc.
view allAdverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
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 K936084
K-number listed on FDA's recall record- Z-0506-2022 — Infant Heel Warmers w/strap, Reference # 989805603201 1223
- Z-0508-2022 — Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
- Z-0509-2022 — Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
- Z-0505-2022 — Infa-Therm Transport Mattress, Reference Number 989805616831 1015
- Z-1316-2016 — evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
- Z-0543-2016 — Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.