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#
- 3008384335
- 3016758972
- 3012316249
- 3017619379
- 3013496867
- 3018269545
- 3011689956
- 3005346101
- 3011103697
- 3033011342
- 3001124136
- 3013034812
- 3032597249
- 3008562183
- 3044563261
- 3031233916
- 3005739529
- 3016050930
- 3015140199
- 2031638
- 3017633586
- 3008386507
- 2435946
- 3020978033
- 3014266447
- 3005271071
- 3016450032
- 3038637162
- 3031589938
- 3021254557
- 3030078769
- 3014204518
- 3005621808
- 3004201320
- 3008742818
- 1450662
- 3005728058
- 3015363935
- 3022147580
- 3017264244
- 2248903
- 2183416
- 3026032283
- 3005621729
- 3013557562
- 3042198580
- 3023809973
- 9021987
- 3015375647
- 3012777736
- 3015422337
- 3010531562
- 3013684902
- 3042277868
- 3038280948
- 3010952189
- 3040274588
- 3006984851
- 3029906227
- 3029952416
- 1043899
- 3015173212
- 3010039589
- 3010409218
- 3009563903
- 1038758
- 3010822231
- 3038718579
- 3005885000
- 3031604327
- 3008973760
- 3008727544
- 3003079019
- 3024088964
- 9615433
- 3006897996
- 3013530901
- 3011191255
- 3031841433
- 3008693666
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