HOT/ICE
FDA 510(k) clearance K830757 · decided 1983-03-29
Clearance details
- K-number
- K830757
- Device name
- HOT/ICE
- Applicant
- Thermo Temp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-10
- Decision date
- 1983-03-29
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Armory Motion (K213097) | Pain Management Technologies, Inc. | 2022-06-10 |
| COOLSKIN (K083008) | Elbio Co., Ltd. | 2009-06-10 |
| T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (K073675) | Gaymar Industries, Inc. | 2008-05-08 |
| JUNIPER CLN1 DERMAL COOLING DEVICE (K072152) | Juniper Medical, Inc. | 2007-09-07 |
| MODIFICATION TO POLAR CARE 500 (K070402) | Breg, Inc. | 2007-03-29 |
| IVC SYSTEM (K040317) | Mark H. Friedman | 2004-05-07 |
| INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (K973023) | Hollister, Inc. | 1997-11-03 |
| HTP-1500 LOCALIZED HEAT THERAPY PUMP (K970197) | Adroit Medical Systems, Inc. | 1997-09-10 |
| ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (K964799) | Ormed GmbH | 1997-08-29 |
| ARTOCOOL-S WATER CIRCULATING COLD PACK (K964354) | Ormed GmbH | 1997-08-29 |
| BLEDSOE COLD CONTROL (K964710) | Med Technology, Inc. | 1997-05-09 |
| MODEL 1100 COLD THERAPY DEVICE (K970533) | Smith & Nephew, Inc. | 1997-04-15 |
Recalls involving this device
No recalls on record reference this clearance.