510(k) K073675
- Device
- T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
- Applicant
- GAYMAR INDUSTRIES, INC.
- 510(k) number
- K073675
- Product code
- ILO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-08
- Date received
- 2007-12-28
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETHANY J GILBERT
- Address
- 140 Pearl St., Suite 100 Buffalo NY US 14202 14202
FDA Registration Numbers#
- 3042254805
- 3015252349
- 3021282523
- 3007649424
- 3003855981
- 1055823
- 1060680
- 3016159364
- 8043817
- 3043140701
- 3015960622
- 3015727296
- 3008236846
- 9613793
- 3007582661
- 3010675856
- 3035374295
- 3007353136
- 3038295706
- 3027328721
- 3003890514
- 2320762
- 3042277508
- 1054241
- 3015489752
- 3009125070
- 3003542872
- 3010160370
- 3030151584
- 9680425
- 3011539161
- 3033648890
- 3043709874
- 3019849074
- 3015907115
- 3007309299
- 3027643666
- 3016171827
- 3027500264
- 3014386328
- 1000548922
- 3004713344
- 2030732
- 3017150671
- 3011191255
- 2011068
- 3023876581
- 1516825
- 1043214
- 3021380980
- 3008523132
- 3009437400
- 3015501220
- 2424387
- 3013069546
- 3011529836
- 9616309
- 9616086
- 3003764610
- 1058584
- 3012841710
- 3011689956
- 3009142693
- 3016915446
- 1528161
- 3015619973
- 3011853381
- 1649518
- 3014542717
- 3013180212
- 1417592
- 3025430561
- 3007109661
- 3011767724
- 2028253
- 1531264
- 2029275
- 3017866840
- 3010694026
Source Documents#
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 |
| 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 |
| K963596 | POLAR CARE 300 | Breg, Inc. | 1996-12-04 |
Legacy Summary#
summary
FDA Review#
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