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FDA 510(k)

THERATHERM

K-Number: K770686 · 1977-07-14

ApplicantElectro Therapeutic Devices, Inc.
Decision Date1977-07-14
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERATHERM is the device name listed in this FDA 510(k) record. The listed applicant is Electro Therapeutic Devices, Inc.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K770686. 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 THERATHERM?

THERATHERM is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Electro Therapeutic Devices, Inc.. The 510(k) number is K770686.

When did THERATHERM receive FDA 510(k) clearance?

THERATHERM received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770686.

Who is the listed applicant for THERATHERM?

The FDA 510(k) record lists Electro Therapeutic Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERATHERM?

The FDA product code for THERATHERM is IRT.

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Other records listing Electro Therapeutic Devices, 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.

K981272ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLESK875317ELECTRICAL MUSCLE STIMULATOR MODEL MYOAIDK863568'MYOSTIM EX'K863567'TENSAID'K853719TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410K853718TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804

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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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