510(k) K103549
- Device
- DENOVO TEDDY GEL INFANT HEEL WARMER
- Applicant
- DENOVO PRODUCTS LLC
- 510(k) number
- K103549
- Product code
- MPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-08
- Date received
- 2010-12-03
- Regulation
- 890.5710
- Classification name
- Infant Heel Warmer (chemical Heat Pack)
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE WALTERS
- Address
- 17051 Alico Commerce Ct. Unit 3 Fort Myers FL US 33967 33967
FDA Registration Numbers#
- 1625392
- 3009963993
- 1417592
- 3016096058
- 3000126629
- 3008955719
- 3005260401
- 3016618143
- 3014982528
- 3016761372
- 3014421917
- 3030419987
- 3018167761
- 1043214
- 3012421607
- 9710505
- 1423537
- 3010039589
- 9616088
- 1216677
- 2320762
- 9616309
- 3038103734
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MPO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022-10-07 |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016-03-18 |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015-05-27 |
| K053254 | INFANT HEEL WARMER BY INTCO | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | Rapid Aid , Ltd. | 2004-05-03 |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | 2004-01-27 |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | 2003-10-22 |
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Florida Medical Industries, Inc. | 1997-02-10 |
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Baxter Healthcare Corp | 1996-06-06 |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Legacy Summary#
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FDA Review#
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