RECOVER INFANT HEEL WARMER (5100)
FDA 510(k) clearance K964523 · decided 1997-02-10
Clearance details
- K-number
- K964523
- Device name
- RECOVER INFANT HEEL WARMER (5100)
- Applicant
- Florida Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-12
- Decision date
- 1997-02-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MPO
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Tarpon Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Infant Heel WarmerTM; Heel Snuggler® (K221154) | International Biomedical | 2022-10-07 |
| Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845) | CooperSurgical, Inc. | 2016-03-18 |
| 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 |
| HEEL SNUGGLER, MODEL 99047 (K040044) | Respironics, Inc. | 2004-01-27 |
| MEDI-HEAT INFANT HEEL WARMER (K032989) | Mediheat, Inc. | 2003-10-22 |
| 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 |
|---|---|---|
| Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended f recall (Z-2443-2015) | Covidien LLC | 2015-08-21 |
| Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended recall (Z-2444-2015) | Covidien LLC | 2015-08-21 |