510(k) K221653
- Device
- InfaTherm Disposable Infant Warming Mattress
- Applicant
- International Biomedical
- 510(k) number
- K221653
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-06
- Date received
- 2022-06-07
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amy Pieper
- Address
- 8206 Cross Park Dr. Austin TX US 78754 78754
FDA Registration Numbers#
- 3007731000
- 3005739529
- 3031789039
- 3003887292
- 3005885000
- 1835458
- 1519375
- 2110420
- 3029906227
- 3023809973
- 3008520652
- 3017222105
- 3015378469
- 3005034064
- 3042277868
- 3042276434
- 3015392301
- 3012865799
- 3027605322
- 3016778706
- 3016450032
- 3012852163
- 3019804885
- 3009512503
- 2320762
- 3027313660
- 3014542717
- 3007145088
- 3014171027
- 3009563903
- 2438774
- 3010580813
- 3005346101
- 3008254127
- 3031841433
- 3002965034
- 3005271071
- 9680222
- 3026032283
- 3026263452
- 3013473968
- 3010675856
- 3013735158
- 3031288561
- 3010039589
- 3004605321
- 1423537
- 3012480535
- 1450662
- 3009655869
- 3012466243
- 1038758
- 3021660236
- 3022147580
- 2214133
- 3013034812
- 1055236
- 1043899
- 3014314976
- 3005630901
- 3008386507
- 3004615451
- 3013658769
- 1417592
- 3010785927
- 3004134939
- 3012552736
- 3013684380
- 3015140199
- 3015337116
- 3035374295
- 3006789548
- 3030671612
- 3011189529
- 3033011342
- 3031232535
- 3013530901
- 3030078769
- 3021254557
Source Documents#
Other 510(k) Records For Product Code IMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 |
| 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#
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
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