510(k) K901834
- Device
- INSTANT ICE PACK
- Applicant
- IMPACT PACKAGING CORP.
- 510(k) number
- K901834
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-03
- Date received
- 1990-04-24
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN R PIKE
- Address
- 770 Sycamore Ave. Suite J-439 Vista CA US 92083 92083
FDA Registration Numbers#
- 3026263452
- 3010383831
- 3007307589
- 3015391081
- 3017619379
- 3008494300
- 3007222534
- 3032619573
- 3003887292
- 3013557562
- 3004134939
- 3009512503
- 3008412545
- 3023809973
- 3042276434
- 3010353405
- 3013226
- 3030417759
- 3014542717
- 3007865243
- 3005728058
- 3013034812
- 3030671612
- 3008427684
- 3014632167
- 3025430795
- 3015108031
- 3008384335
- 3010951384
- 3041276890
- 3021595883
- 3011103697
- 3013298431
- 3013354376
- 1320681
- 3011118556
- 2248903
- 3012241417
- 3013374101
- 3031232535
- 3009540516
- 3011919098
- 3010409218
- 9021987
- 9616086
- 3010580813
- 3017264244
- 3013530901
- 3016450032
- 3034629348
- 3034669683
- 3006455037
- 3010934856
- 3008727544
- 3002965034
- 3015378469
- 3015058854
- 3010822231
- 3006210673
- 3018387315
- 3018269545
- 3044735702
- 3011983031
- 3027605322
- 1836161
- 3021841055
- 3012316249
- 3009655869
- 3025440611
- 3007407626
- 3005343641
- 3005885000
- 2320762
- 3008392711
- 3005023997
- 3004857344
- 3005761322
- 3010097863
- 1250045
- 3015140199
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 |
| 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 |
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