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FDA 510(k)

THERA-PAK

K-Number: K780452 · 1978-06-21

ApplicantHydro-Med Products, Inc.
Decision Date1978-06-21
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERA-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Hydro-Med Products, Inc.. It received FDA 510(k) clearance on 1978-06-21 under 510(k) number K780452. 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 THERA-PAK?

THERA-PAK is a medical device that received FDA 510(k) clearance on 1978-06-21. The listed applicant is Hydro-Med Products, Inc.. The 510(k) number is K780452.

When did THERA-PAK receive FDA 510(k) clearance?

THERA-PAK received FDA 510(k) clearance on 1978-06-21, under 510(k) number K780452.

Who is the listed applicant for THERA-PAK?

The FDA 510(k) record lists Hydro-Med Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERA-PAK?

The FDA product code for THERA-PAK is ILO.

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Other records listing Hydro-Med Products, Inc. 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.

K944198SURGICAL MICROSCOPE DRAPEK940151ULTRASOUND PROBE DRAPEK934630UNIVERSAL VIDEO/LASER ARM DRAPEK940152CAMERA COVER WITH TEAR TIPK923099X-RAY DRAPESK863872TAMPER HAMPER

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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

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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