510(k) K112547
- Device
- NEO NEST
- Applicant
- DENOVO PROUCTS LLC
- 510(k) number
- K112547
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-06
- Date received
- 2011-09-01
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- 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. #3 Ft. Myers FL US 33967 33967
FDA Registration Numbers#
- 3007731000
- 3031841433
- 3008808560
- 3008184628
- 3042277215
- 3005113602
- 3017417635
- 3008485841
- 3043648115
- 3038624153
- 3007307589
- 3015391081
- 3015392301
- 3010045207
- 3007838093
- 3008048783
- 3031256651
- 3014982528
- 3006234743
- 3007607706
- 3005271071
- 3005761322
- 3009563903
- 8030607
- 3038283966
- 3017896419
- 3042284335
- 3012777736
- 3038637162
- 1417592
- 3005460813
- 3009655869
- 3005906953
- 3015337116
- 3012241417
- 3016585381
- 3023141635
- 3010041486
- 3014204518
- 3007649424
- 3026593440
- 3006416350
- 3034669683
- 3008384335
- 3004201320
- 1025972
- 3014314976
- 3015363935
- 3015272250
- 3004824601
- 3014065673
- 3042277868
- 3031232535
- 3031288561
- 3008955719
- 3045526618
- 3003674698
- 3008973760
- 3013684380
- 3010822231
- 3005023997
- 3012783431
- 3035374295
- 3011526963
- 3005533873
- 3016195105
- 3008727544
- 3041276890
- 3027605322
- 3003887292
- 3023341288
- 3039396083
- 3044466317
- 3011689956
- 3006897996
- 3038220293
- 3032619573
- 3014266447
- 3013658769
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases