Data / Medical devices / United States / Life Recovery Systems HD, LLC.
Life Recovery Systems HD, LLC.: FDA-registered device maker in Kinnelon, NJ, United States, 1 510(k) clearance
Life Recovery Systems HD, LLC. is registered with the FDA (registration 3006059109) in Kinnelon, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 20, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006059109
- Address
- 170 Kinnelon Rd, Kinnelon, NJ, United States, 07405
- Owner or operator
- LIFE RECOVERY SYSTEMS HD, LLC. (9095304)
- Roles
- Manufacturer
- First device listed
- December 5, 2006
- Registered through
- 2026
- Brand names listed
- THERMOSUIT SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hyperthermia Monitor | NZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 20, 2006 | K061023 | THERMOSUIT SYSTEM | NZE | Substantially Equivalent | Life Recovery Systems Hd, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 21, 2011 | 60636 | Not yet classified | Terminated | ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: FAx.: Temperature reduction in patients where clinically indicated; Monitoring of patient temperature | ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading. | accessdata.fda.gov |
Compare with other makers
Updated January 11, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.