510(k) K980509
- Device
- DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
- Applicant
- DEROYAL INDUSTRIES, INC.
- 510(k) number
- K980509
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-26
- Date received
- 1998-02-10
- 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
- CAMILLE MATLOCK
- Address
- 200 Debusk Ln. Powell TN US 37849 37849
FDA Registration Numbers#
- 3013354376
- 3007307589
- 3008216220
- 3013557562
- 3008955719
- 1038758
- 3031606416
- 3018077452
- 3013684902
- 1060680
- 3005533873
- 3016719957
- 3017166480
- 3030412776
- 3005113602
- 3015422337
- 3008184628
- 1032347
- 3015525234
- 3025430795
- 3016050930
- 3042277868
- 3005460813
- 3010952189
- 3024689458
- 3016757941
- 3005739529
- 3006210673
- 1925025
- 8043323
- 3020978033
- 3013684380
- 9680689
- 3004993527
- 3015339737
- 3026263452
- 3005034064
- 3007187674
- 1320681
- 3006122980
- 3008386507
- 1423537
- 3012841710
- 3006455037
- 3034629348
- 3010039589
- 3017633586
- 3008951115
- 3011118556
- 3030222360
- 3014204518
- 3017041963
- 1055236
- 3031589938
- 3006008854
- 3001124136
- 3015337116
- 3016450032
- 3016861904
- 3012034017
- 1054241
- 3015220641
- 3004605321
- 3004617746
- 3027517726
- 3014542717
- 3006416350
- 3008973760
- 3014632167
- 3010045207
- 9616309
- 3024891479
- 3014982528
- 3018167761
- 9616096
- 3014266447
- 1450530
- 3017417635
- 3038637162
- 3038220293
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 |
| 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#
summary
FDA Review#
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