510(k) K221653
- Device
- InfaTherm Disposable Infant Warming Mattress
- Applicant
- International Biomedical
- 510(k) number
- K221653
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-06
- Date received
- 2022-06-07
- 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
- Amy Pieper
- Address
- 8206 Cross Park Dr. Austin TX US 78754 78754
FDA Registration Numbers#
- 3023809973
- 3015108031
- 3010353405
- 3006157842
- 3008216220
- 3010952189
- 3013354376
- 1250045
- 3026263452
- 3008562183
- 3014982528
- 3004857344
- 3030222360
- 3007593958
- 3005621808
- 3015341499
- 3030498909
- 3008254127
- 1836161
- 1422399
- 3031256651
- 3031288561
- 3021595883
- 3042252791
- 3031595576
- 8030607
- 2031094
- 3006008854
- 3011182985
- 1319302
- 3003255790
- 3034629348
- 3041276890
- 3003887292
- 3006122980
- 3031589938
- 3008392711
- 3018326554
- 3009171220
- 3004102812
- 3003674698
- 9021987
- 3015397169
- 3008386507
- 3016955900
- 3030726486
- 1055236
- 1025972
- 3012314549
- 2031638
- 3008676146
- 9616309
- 3015220641
- 3013557562
- 3004134939
- 3036893546
- 3013735158
- 1423537
- 3015337116
- 3007865243
- 3005621729
- 3013226
- 2427500
- 2110420
- 3042277868
- 9680689
- 1216677
- 9616096
- 3017222105
- 3007731000
- 3042896810
- 3020978033
- 3014421917
- 3000268902
- 1043899
- 3016816791
- 2248903
- 3027605322
- 3007222534
- 3006210673
Source Documents#
Other 510(k) Records For Product Code IMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 |
Legacy Summary#
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FDA Review#
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