510(k) K970399
- Device
- KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
- Applicant
- ALLEGIANCE HEALTHCARE CORP.
- 510(k) number
- K970399
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-03
- Date received
- 1997-02-03
- 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
- MARYALICE SMITH
- Address
- 1660 Iowa Ave., Suite 100/200 Riverside CA US 92507 92507
FDA Registration Numbers#
- 3042277215
- 2415591
- 3010934856
- 9616309
- 3002965034
- 3045058049
- 3010872396
- 3017859599
- 3014268334
- 3013496867
- 3038199417
- 3006122980
- 3003887292
- 3017591220
- 3007222546
- 3017103360
- 1250045
- 3008048783
- 3015344405
- 3030412776
- 3016758972
- 3016955900
- 1043899
- 3008520652
- 3012480535
- 3022833366
- 3018077452
- 2435946
- 1060680
- 3010097863
- 3008254127
- 3042252791
- 3016450032
- 3013530901
- 3008676146
- 3035451914
- 3007649424
- 9710567
- 3026032283
- 3005569927
- 3024088964
- 3015378469
- 1055236
- 3003255790
- 3027157200
- 3014065673
- 3012314549
- 2082295
- 3010785927
- 3010041486
- 3031841433
- 1216677
- 9681544
- 3031606416
- 3008562183
- 3003079019
- 3009540516
- 3041276890
- 3010951382
- 1320681
- 3009655869
- 3005083505
- 3032597249
- 3018269545
- 3034694939
- 3022147580
- 3025194213
- 1925025
- 3024689458
- 9680222
- 3031288561
- 2214133
- 3008742818
- 1060934
- 3005113602
- 3011191255
- 3008494300
- 1423537
- 3031604327
- 9680689
Source Documents#
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 |
| 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 |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 |
Legacy Summary#
summary
FDA Review#
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