510(k) K163295
- Device
- Infant Transport Mattress Warmer With Disc
- Applicant
- RAPID AID CORP.
- 510(k) number
- K163295
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-24
- Date received
- 2016-11-22
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laureta Prifti
- Address
- 4120 A Sladeview Cresent Mississauga CA L5L 5Z3 L5L 5Z3
FDA Registration Numbers#
- 3042277868
- 3005906953
- 2248903
- 3022833366
- 3015414875
- 3007649424
- 1060680
- 3015391081
- 3005034064
- 3040274588
- 3024891479
- 3008048783
- 3022147580
- 3008727544
- 3004102812
- 3007187674
- 1060934
- 3012316249
- 2415591
- 3010951384
- 2183416
- 3011191255
- 3015341499
- 3013632692
- 9710505
- 3015058854
- 3009486864
- 2110420
- 3021590259
- 3013354376
- 3011189529
- 3013658769
- 3013557562
- 3011983031
- 3004857344
- 3013530901
- 3014542717
- 1417592
- 3008392711
- 3007439125
- 1835458
- 3023809973
- 3041276890
- 3016450032
- 3005885000
- 3011248163
- 1320681
- 3008494033
- 3030488262
- 1216677
- 3018326554
- 3002965034
- 3004201320
- 2031638
- 3006897996
- 3038624153
- 3018077452
- 3002324535
- 3017859599
- 3026032283
- 3015140199
- 3004727093
- 3011919098
- 3030412776
- 3005271071
- 3008742818
- 3012314549
- 3024689458
- 3012552736
- 3005853033
- 3007607706
- 3042277215
- 3010041486
- 3010198795
- 3010370474
- 1420763
- 3029906227
- 3013473968
- 3038718579
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 |
| 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 |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 |
Legacy Summary#
summary
FDA Review#
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