510(k) K954095
- Device
- MEDICOOL (MODIFICATON)
- Applicant
- MICROCLIMATE SYSTEMS, INC.
- 510(k) number
- K954095
- Product code
- ILO
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1996-03-06
- Date received
- 1995-08-20
- Regulation
- 890.5720
- Classification name
- Pack, Hot Or Cold, Water Circulating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS E DUNN
- Address
- 965 S. Saginaw Rd. Sanford MI US 48657 48657
FDA Registration Numbers#
- 1000548922
- 1648700
- 2029275
- 3015252349
- 3016159364
- 3017555752
- 3015619973
- 3009125070
- 3025034781
- 3011491271
- 3003855981
- 2011068
- 3010960892
- 3027500264
- 3021380980
- 3033648890
- 1723702
- 3012841710
- 3032062344
- 3021282523
- 3003619590
- 3038295706
- 2028253
- 3010694026
- 3007774549
- 3030151584
- 3013180212
- 3007649424
- 1054241
- 9680425
- 2424387
- 3026294985
- 3008724689
- 9611500
- 1927395
- 9611559
- 3011539161
- 3008523132
- 3008395114
- 3011853381
- 3013069546
- 3014264913
- 3017965926
- 3007582661
- 3004116008
- 9616086
- 3017866840
- 3010675856
- 1055823
- 3007109661
- 3030648824
- 3017202421
- 3025430561
- 1649518
- 3015489752
- 3033511104
- 3009437400
- 1531264
- 3043140701
- 9613793
- 3027328721
- 3007309299
- 3009155756
- 1835315
- 3007543825
- 3011529836
- 3030478415
- 1060680
- 3007353136
- 3009142693
- 3023876581
- 1043214
- 2320762
- 3016915446
- 3017264244
- 8043817
- 1417592
- 3043709874
- 1516825
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022-06-10 |
| K083008 | COOLSKIN | Elbio Co., Ltd. | 2009-06-10 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | 2008-05-08 |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | 2007-09-07 |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | 2007-03-29 |
| K040317 | IVC SYSTEM | Mark H. Friedman | 2004-05-07 |
| K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | 1997-11-03 |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | 1997-09-10 |
| K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | 1997-08-29 |
| K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | 1997-08-29 |
| K964710 | BLEDSOE COLD CONTROL | Med Technology, Inc. | 1997-05-09 |
| K970533 | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | 1997-04-15 |
| K962983 | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | 1997-01-10 |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | 1996-12-31 |
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | 1996-12-31 |
Legacy Summary#
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FDA Review#
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