510(k) K953542
- Device
- COLDGEL
- Applicant
- PRISM TECHNOLOGIES, INC.
- 510(k) number
- K953542
- Product code
- IMD
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1995-10-30
- Date received
- 1995-07-28
- 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
- HOWARD M HOLSETIN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3038283966
- 1319302
- 3007865243
- 1423537
- 3008774899
- 3003674698
- 9021987
- 3012552736
- 3034669683
- 3007299770
- 3015525234
- 3031841433
- 3016955900
- 3038613041
- 3006122980
- 3035451914
- 2438774
- 3017417635
- 3005885000
- 3007593958
- 1054241
- 3021595883
- 3017633586
- 1032347
- 9710505
- 9680284
- 1121142
- 3025413691
- 3012865799
- 9616086
- 3022147580
- 3010041486
- 3008386507
- 3031604327
- 3030222360
- 3044466317
- 3041276890
- 3038199417
- 3012309743
- 3015277818
- 3017103360
- 1038758
- 3009155756
- 3005630901
- 3027517726
- 3018167761
- 3032619573
- 3016719957
- 2320762
- 3006943846
- 3005023997
- 3013034812
- 3015140199
- 3007222546
- 9710567
- 3008808560
- 3004727093
- 3013684902
- 3017619379
- 3026032283
- 1043899
- 3030498909
- 3008693666
- 3015344405
- 3000126629
- 3021660236
- 3031184338
- 3015375647
- 3008384335
- 3008676146
- 3002324535
- 3010370474
- 3014632167
- 3015414875
- 3029906227
- 3010966625
- 3025430795
- 3007407626
- 3014683120
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