510(k) K936084
- Device
- OMNI WARM GEL PACKS
- Applicant
- OMNI THERM, INC.
- 510(k) number
- K936084
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-31
- Date received
- 1993-12-21
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE E WALTERS
- Address
- 2338 Weldon Pkwy. St. Louis MO US 63146 63146
FDA Registration Numbers#
- 3005853033
- 3013735158
- 3022147580
- 3031256651
- 3008754100
- 1925025
- 3031180757
- 1625392
- 3043654665
- 2415591
- 3042277215
- 3017591220
- 3008494033
- 2438774
- 3013354376
- 3006517436
- 3044466317
- 3016758972
- 3031789039
- 2031094
- 3011189529
- 3030671612
- 1060934
- 3011298700
- 3008254127
- 3017619379
- 3012480535
- 3008951115
- 1422399
- 3008258694
- 3010045207
- 3038220293
- 3031589938
- 3012841710
- 3026593440
- 3014632167
- 2248903
- 3004134939
- 3010097863
- 3010374920
- 1055236
- 3015422337
- 1319302
- 3008973760
- 3017166480
- 3040274588
- 3013865802
- 3010041486
- 3004615451
- 9710505
- 3007407626
- 3034669683
- 3024891479
- 1423537
- 3005533873
- 3015344405
- 3021841055
- 3015397169
- 3013496867
- 3008427684
- 3012777736
- 3014421917
- 3008808082
- 3006210673
- 3007439125
- 3017222105
- 3003674698
- 3023341288
- 3004824601
- 3027517726
- 3011182985
- 3016171962
- 1250045
- 3030412776
- 3009155756
- 3006789548
- 3031604327
- 3008048783
- 3013374101
- 3015392301
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