HEEL SNUGGLER, MODEL 99047
FDA 510(k) clearance K040044 · decided 2004-01-27
Clearance details
- K-number
- K040044
- Device name
- HEEL SNUGGLER, MODEL 99047
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-12
- Decision date
- 2004-01-27
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- MPO
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Murrysville, PA, US
- Third-party review
- Yes
- Expedited review
- No
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|---|---|---|
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| Rapid Aid Instant Disposable Infant Heel Warmer (K150627) | Rapid Aid Corp. | 2015-05-27 |
| DENOVO TEDDY GEL INFANT HEEL WARMER (K103549) | Denovo Products, LLC | 2011-04-08 |
| INFANT HEEL WARMER BY INTCO (K053254) | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (K040856) | Rapid Aid , Ltd. | 2004-05-03 |
| MEDI-HEAT INFANT HEEL WARMER (K032989) | Mediheat, Inc. | 2003-10-22 |
| RECOVER INFANT HEEL WARMER (5100) (K964523) | Florida Medical Industries, Inc. | 1997-02-10 |
| BAXTER SODIUM ACETATE INFANT HEEL WARMER (K961154) | Baxter Healthcare Corp | 1996-06-06 |
| DEROYAL INDUSTRIES INFANT HEEL WARMER (K954716) | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Heel Snuggler, Reference # 989805603411 99047 recall (Z-0507-2022) | Philips North America Llc | 2022-01-19 |