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FDA 510(k)

THERMO TRIM

K-Number: K852637 · 1985-11-20

ApplicantSuntec Health & Fitness Group, Inc.
Decision Date1985-11-20
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMO TRIM is the device name listed in this FDA 510(k) record. The listed applicant is Suntec Health & Fitness Group, Inc.. It received FDA 510(k) clearance on 1985-11-20 under 510(k) number K852637. 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 THERMO TRIM?

THERMO TRIM is a medical device that received FDA 510(k) clearance on 1985-11-20. The listed applicant is Suntec Health & Fitness Group, Inc.. The 510(k) number is K852637.

When did THERMO TRIM receive FDA 510(k) clearance?

THERMO TRIM received FDA 510(k) clearance on 1985-11-20, under 510(k) number K852637.

Who is the listed applicant for THERMO TRIM?

The FDA 510(k) record lists Suntec Health & Fitness Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMO TRIM?

The FDA product code for THERMO TRIM 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 Suntec Health & Fitness Group, 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.

K864558U66 EMS

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

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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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