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FDA 510(k)

THERMOAIRE SPLINT (TM) (TAS)

K-Number: K900356 · 1990-05-07

ApplicantLife Enhancement Technologies, LLC
Decision Date1990-05-07
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMOAIRE SPLINT (TM) (TAS) is the device name listed in this FDA 510(k) record. The listed applicant is Life Enhancement Technologies, LLC. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K900356. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOAIRE SPLINT (TM) (TAS)?

THERMOAIRE SPLINT (TM) (TAS) is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Life Enhancement Technologies, LLC. The 510(k) number is K900356.

When did THERMOAIRE SPLINT (TM) (TAS) receive FDA 510(k) clearance?

THERMOAIRE SPLINT (TM) (TAS) received FDA 510(k) clearance on 1990-05-07, under 510(k) number K900356.

Who is the listed applicant for THERMOAIRE SPLINT (TM) (TAS)?

The FDA 510(k) record lists Life Enhancement Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOAIRE SPLINT (TM) (TAS)?

The FDA product code for THERMOAIRE SPLINT (TM) (TAS) is ILO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Life Enhancement Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K900355MARK VII THERMOREGULATION ASSIST SYSTEMK873200KARLSON OZONE STERILIZER MODEL 100B

Related Devices (Code: ILO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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