Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket
K031728 is the FDA 510(k) clearance record for KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET, a class II device, cleared for Klimamed Technologie Medizingerate GmbH on under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 2 510(k) clearances for Klimamed Technologie Medizingerate GmbH, from to . As of , FDA records show no recalls naming K031728.
Clearance record
- Decision date
- Received
- (496 days to decision)
- Product code
- DWJ System, Thermal Regulating
- Regulation
- 21 CFR 870.5900
- Device class
- Class II
- Review panel
- Cardiovascular
- Applicant
- Klimamed Technologie Medizingerate GmbH 1380 Lead Hill Blvd., Roseville CA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code DWJ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 2 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 2 |
| September 2026 | 0 |
| October 2026 | 0 |
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