510(k) K941245
- Device
- POLY-MEDICS HEAT PACK
- Applicant
- BIOMET, INC.
- 510(k) number
- K941245
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-02
- Date received
- 1994-03-15
- 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
- MARY VERSTYNEN
- Address
- Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 9681544
- 3004727093
- 3004824601
- 3007407626
- 3011118556
- 3015375647
- 3013735158
- 3019804885
- 1121142
- 2320762
- 3036893546
- 3008048783
- 3011526963
- 1250045
- 3015277818
- 3010182295
- 3038624153
- 2183416
- 3007607706
- 3005271071
- 3011182985
- 3009538555
- 3016719957
- 1925025
- 3005260401
- 3003674698
- 3005034064
- 9616088
- 2082295
- 3035374295
- 3029906227
- 3021595883
- 3008386507
- 2031094
- 3016746332
- 2438774
- 3007731000
- 3023917
- 9680222
- 3011298700
- 3005951403
- 3008392711
- 3031288561
- 2427500
- 3016195105
- 3018387315
- 3013684380
- 8030358
- 3027605322
- 3006210673
- 3030726486
- 3018077452
- 3013557562
- 3008808560
- 3012316249
- 3006234743
- 3030488262
- 3006707030
- 3007865243
- 3031589938
- 3007307589
- 3025440611
- 3013632692
- 3016585381
- 3009303243
- 1836161
- 3008174904
- 3008427684
- 3016096058
- 2415591
- 3003887292
- 3014982528
- 3005569927
- 3010822231
- 3015391081
- 3021660236
- 3031232535
- 3012777736
- 3012466243
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 |
| 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