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FDA 510(k)

BODY COOLER OR COOLVEST OR ALPHA BODY COOLER

K-Number: K891603 · 1989-07-25

ApplicantAlpha Rehabilitation Products
Decision Date1989-07-25
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BODY COOLER OR COOLVEST OR ALPHA BODY COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Rehabilitation Products. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K891603. 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 BODY COOLER OR COOLVEST OR ALPHA BODY COOLER?

BODY COOLER OR COOLVEST OR ALPHA BODY COOLER is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Alpha Rehabilitation Products. The 510(k) number is K891603.

When did BODY COOLER OR COOLVEST OR ALPHA BODY COOLER receive FDA 510(k) clearance?

BODY COOLER OR COOLVEST OR ALPHA BODY COOLER received FDA 510(k) clearance on 1989-07-25, under 510(k) number K891603.

Who is the listed applicant for BODY COOLER OR COOLVEST OR ALPHA BODY COOLER?

The FDA 510(k) record lists Alpha Rehabilitation Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY COOLER OR COOLVEST OR ALPHA BODY COOLER?

The FDA product code for BODY COOLER OR COOLVEST OR ALPHA BODY COOLER is ILO.

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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

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

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