510(k) K790993
- Device
- INSTANT HOT & COLD PACKS
- Applicant
- CHASE MFG. CO.
- 510(k) number
- K790993
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-07
- Date received
- 1979-05-29
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1060934
- 3013658769
- 3005533873
- 3038103734
- 3030488262
- 3008494300
- 1836546
- 3013298431
- 3005761322
- 3021254557
- 3038199417
- 3007307589
- 3042284335
- 1038758
- 3020978033
- 3012309743
- 1420763
- 1121142
- 1835458
- 3005728058
- 3008676146
- 3010383831
- 3012034017
- 3013735158
- 3011191255
- 8030358
- 3023141635
- 3040274588
- 3031256651
- 3006157842
- 3013226
- 3010531562
- 3025413691
- 3012314549
- 3024891479
- 3011182985
- 3044735702
- 3007439125
- 3004134939
- 3010580813
- 3006707030
- 3007838093
- 3013684902
- 3013632692
- 1519375
- 3005951403
- 3013034812
- 3038283966
- 3038624153
- 3013374101
- 3012783431
- 3029996046
- 3008216220
- 3008258694
- 3011248163
- 3014683120
- 3013865802
- 3016050930
- 9680222
- 3017299525
- 3042277215
- 3007222534
- 3010951382
- 1320681
- 3042276434
- 3027517726
- 3031582449
- 3005739529
- 2031638
- 2438774
- 3031606416
- 3006517436
- 3005630901
- 3007731000
- 3031595576
- 3008973760
- 3015220641
- 1417592
- 3015414875
- 3015337116
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#
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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