OMNI WARM GEL PACKS
FDA 510(k) clearance K936084 · decided 1994-03-31
Clearance details
- K-number
- K936084
- Device name
- OMNI WARM GEL PACKS
- Applicant
- Omni Therm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-21
- Decision date
- 1994-03-31
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infant Heel Warmers w/strap, Reference # 989805603201 1223 recall (Z-0506-2022) | Philips North America Llc | 2022-01-19 |
| Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T recall (Z-0508-2022) | Philips North America Llc | 2022-01-19 |
| Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 recall (Z-0509-2022) | Philips North America Llc | 2022-01-19 |
| Infa-Therm Transport Mattress, Reference Number 989805616831 1015 recall (Z-0505-2022) | Philips North America Llc | 2022-01-18 |
| evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer fo recall (Z-1316-2016) | Philips Electronics North America Corporation | 2016-04-04 |
| Cardinal Health Tiny Toes; 11470-010T Infant heel warmer recall (Z-0543-2016) | Philips Electronics North America Corporation | 2015-12-24 |