THERMOCOOL SYSTEM
FDA 510(k) clearance K950395 · decided 1995-08-18
Clearance details
- K-number
- K950395
- Device name
- THERMOCOOL SYSTEM
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-02-01
- Decision date
- 1995-08-18
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Dover, OH, US
- Third-party review
- No
- Expedited review
- No
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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |