510(k) K890553
- Device
- CP&S DISPOSABLE INSTANT COLD COMPRESS
- Applicant
- CONSOLIDATED PRODUCTS & SERVICES, INC.
- 510(k) number
- K890553
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-13
- Date received
- 1989-02-06
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD MCMANUS
- Address
- 30 Fayette St. North Quincy MA US 02171 02171
FDA Registration Numbers#
- 3021590259
- 3005951403
- 3006517436
- 3015220641
- 3030498909
- 3010374920
- 8030607
- 1319302
- 3015414875
- 3010872396
- 3014632167
- 3015378469
- 3011189529
- 9021987
- 3005460813
- 3015272250
- 3008392711
- 3007307589
- 3045058049
- 3010383831
- 3043648115
- 3014268334
- 9710567
- 1250045
- 3016757941
- 3038283966
- 3010039589
- 3016955900
- 3023141635
- 3000268902
- 3013226
- 3042252791
- 9616096
- 3017417635
- 3036893546
- 3013735158
- 2082295
- 1320681
- 3008742818
- 3005533873
- 3012783431
- 3004824601
- 3007731000
- 3012421607
- 1423537
- 3008808082
- 3018077452
- 3013354376
- 9680689
- 3010934856
- 1422399
- 3015391081
- 3011191255
- 3038191347
- 3024891479
- 3000682787
- 3029952416
- 3008412545
- 3038295725
- 3006157842
- 3005621729
- 3013530901
- 3038624153
- 3015526491
- 3032597249
- 3029996046
- 3004993527
- 3013658769
- 3014421917
- 1835458
- 3027517726
- 3039396083
- 3008955719
- 3014171027
- 3011248163
- 3015337116
- 1450530
- 3017859599
- 3038718579
- 3011182985
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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