Life Recovery Systems HD, LLC

Kinnelon, NJ, US

LIFE RECOVERY SYSTEMS HD, LLC. appears in FDA device records in Kinnelon, NJ. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Life Recovery Systems HD, LLC in 2006.

Clearances by year, as a table

510(k) clearance decisions for Life Recovery Systems HD, LLC, by decision year
Year	Clearances
2006	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K061023	THERMOSUIT SYSTEM	NZE	Substantially Equivalent	2006-09-20

Registered establishments

FDA registered establishments for Life Recovery Systems HD, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3006059109	3006059109	LIFE RECOVERY SYSTEMS HD, LLC.	170 Kinnelon Rd, Kinnelon, NJ 07405 US	2026	NZE

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

NZEHyperthermia Monitor

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0456-2012	ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 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.		2011-10-21	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain