510(k) K955788
- Device
- IMNI HOT PACKS
- Applicant
- OMNI THERM, INC.
- 510(k) number
- K955788
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-04
- Date received
- 1995-12-22
- 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
- MATT WALTERS
- Address
- 2338 Weldon Pkwy. St. Louis MO US 63146 63146
FDA Registration Numbers#
- 3044563261
- 3012852163
- 3010182295
- 3014204518
- 3038295725
- 3004134939
- 3016758972
- 3013226
- 3010872396
- 3012680643
- 9680689
- 3010409218
- 3025440611
- 3021595883
- 3009486864
- 3015339737
- 2110420
- 3012841710
- 3031582449
- 9680222
- 9616309
- 3014301546
- 3026263452
- 3038637162
- 1060680
- 3013632692
- 3006517436
- 3014683120
- 3007407626
- 3010580813
- 3016778706
- 3044466317
- 3008693666
- 3011298700
- 3007607706
- 3013684380
- 2427500
- 3041276890
- 3008485841
- 3010383831
- 3012316249
- 8030358
- 1420763
- 3023141635
- 3015344405
- 3005761322
- 3008494033
- 3029906227
- 3010952189
- 3013684902
- 1625392
- 3008216220
- 3004857344
- 3017859599
- 3007731000
- 3023809973
- 3005034064
- 3042276434
- 3015391081
- 3013354376
- 3014268334
- 1043214
- 1060934
- 3015392301
- 3005885000
- 3016426842
- 3042896810
- 3009155756
- 3005023997
- 3008386507
- 9710567
- 3005739529
- 3005621808
- 3008392711
- 3042198580
- 3031256651
- 3011182985
- 3013865802
- 3027605322
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#
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