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FDA 510(k)

DYNATRON 125 ULTRASOUND

K-Number: K961250 · 1996-08-26

ApplicantDynatronics Corp.
Decision Date1996-08-26
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNATRON 125 ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Dynatronics Corp.. It received FDA 510(k) clearance on 1996-08-26 under 510(k) number K961250. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNATRON 125 ULTRASOUND?

DYNATRON 125 ULTRASOUND is a medical device that received FDA 510(k) clearance on 1996-08-26. The listed applicant is Dynatronics Corp.. The 510(k) number is K961250.

When did DYNATRON 125 ULTRASOUND receive FDA 510(k) clearance?

DYNATRON 125 ULTRASOUND received FDA 510(k) clearance on 1996-08-26, under 510(k) number K961250.

Who is the listed applicant for DYNATRON 125 ULTRASOUND?

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

What is the FDA product code for DYNATRON 125 ULTRASOUND?

The FDA product code for DYNATRON 125 ULTRASOUND is IMI.

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Other records listing Dynatronics Corp. 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.

K113250DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBEK060814DYNATRON ION IONTOPHORESIS ELECTRODEK051680DYNATRON DX2 TRACTION UNITK051261DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBEK043047DYNATRON IBOX IONTOPHORESIS DEVICEK040729SOLARIS D890 THERAPY PROBE

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Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , 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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