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FDA 510(k)

TRUE-TRAC, STRATUS

K-Number: K926316 · 1993-03-24

ApplicantHenley Intl.
Decision Date1993-03-24
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRUE-TRAC, STRATUS is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1993-03-24 under 510(k) number K926316. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE-TRAC, STRATUS?

TRUE-TRAC, STRATUS is a medical device that received FDA 510(k) clearance on 1993-03-24. The listed applicant is Henley Intl.. The 510(k) number is K926316.

When did TRUE-TRAC, STRATUS receive FDA 510(k) clearance?

TRUE-TRAC, STRATUS received FDA 510(k) clearance on 1993-03-24, under 510(k) number K926316.

Who is the listed applicant for TRUE-TRAC, STRATUS?

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

What is the FDA product code for TRUE-TRAC, STRATUS?

The FDA product code for TRUE-TRAC, STRATUS is JFB.

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Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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Related Devices (Code: JFB)

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.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.

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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