Geratherm SOS-Rescue Blanket
510(k) K051097
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051097 | Date24 Feb 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Geratherm SOS-Rescue Blanket is a thermal regulating system designed for hypothermia prevention and treatment. It is a portable, electrically heated blanket intended to maintain or restore core body temperature in patients at risk of or experiencing hypothermia, particularly in emergency and critical care settings.
This single-use, non-sterile device is supplied as a disposable blanket and is intended for use in environments where rapid thermal intervention is required, such as pre-hospital emergency care or clinical resuscitation. It operates on a portable power source and is classified as a Class II medical device under FDA regulations (DWJ, 870.5900). The device is authorized for use in the United States via an FDA 510(k) clearance (K051097) and is substantively equivalent to predicate thermal regulating systems.
Other devices from Rg Ent., Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is the Geratherm SOS-Rescue Blanket primarily intended for, and how does it differ from standard warming blankets?
The Geratherm SOS-Rescue Blanket is specifically designed for hypothermia prevention and treatment in emergency and critical care settings, such as pre-hospital care or resuscitation scenarios. Unlike standard warming blankets, it is a portable, electrically heated system that provides rapid thermal intervention to maintain or restore core body temperature in patients at risk of or already experiencing hypothermia. Its single-use, disposable nature and compact design make it ideal for high-mobility environments where quick deployment is critical.
Is the Geratherm SOS-Rescue Blanket reusable, and if not, what does this mean for inventory management?
No, the Geratherm SOS-Rescue Blanket is intended for single-use only, meaning each blanket is designed for one-time application before disposal. This simplifies inventory management by eliminating the need for cleaning, sterilization, or reuse procedures, though it does require stocking multiple units for repeated use in emergency scenarios. The non-sterile designation also means it is not intended for surgical or invasive procedures.
How is the Geratherm SOS-Rescue Blanket powered, and what considerations should be made for its use in field settings?
The Geratherm SOS-Rescue Blanket operates on a portable power source, making it suitable for use in field settings like pre-hospital emergency care or clinical resuscitation where access to standard electrical outlets may be limited. Clinicians should ensure the portable power source is fully charged and compatible with the blanket’s specifications to maintain consistent heating performance during critical interventions.
What regulatory pathway was followed for FDA clearance of the Geratherm SOS-Rescue Blanket, and what does this mean for its use in the U.S.?
The Geratherm SOS-Rescue Blanket received FDA 510(k) clearance (K051097) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to predicate thermal regulating systems. This clearance confirms its compliance with U.S. regulatory standards for Class II medical devices (product code DWJ) and allows its authorized use in the United States for hypothermia prevention and treatment in emergency and critical care settings.