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FDA 510(k)

DELUXE HEAT WRAP/COLD WRAP

K-Number: K801081 · 1980-05-14

ApplicantThe Gillette Company
Decision Date1980-05-14
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DELUXE HEAT WRAP/COLD WRAP is the device name listed in this FDA 510(k) record. The listed applicant is The Gillette Company. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K801081. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELUXE HEAT WRAP/COLD WRAP?

DELUXE HEAT WRAP/COLD WRAP is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is The Gillette Company. The 510(k) number is K801081.

When did DELUXE HEAT WRAP/COLD WRAP receive FDA 510(k) clearance?

DELUXE HEAT WRAP/COLD WRAP received FDA 510(k) clearance on 1980-05-14, under 510(k) number K801081.

Who is the listed applicant for DELUXE HEAT WRAP/COLD WRAP?

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

What is the FDA product code for DELUXE HEAT WRAP/COLD WRAP?

The FDA product code for DELUXE HEAT WRAP/COLD WRAP is IRT.

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 The Gillette Company 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.

K791603GILLETTE CORDLESS WHIRLPOOLK790374GILLETTE HEAT WRAP

Related Devices (Code: IRT)

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.

K250047bite away twomibeTec GmbHK220514bite away neomibeTec GmbHK160943Bite AwayRiemser PharmaK111273FIR HEAT THERAPHY SYSYEMSShenzhen Anpan Technology Co., Ltd.K072534BIO-MAT 2000Richway Intl., Inc.K963887PT-PAC PORTABLE HEATING PADAnthony A. Chiurco

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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