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Sonopuls 434 Ultrasound Therapy Equipment

by Fluidotherapy Corp.

510(k) K850640

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850640 Date14 May 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IMI
Device Class
Class II
Regulation
21 CFR Part 890.5300
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sonopuls 434 Ultrasound Therapy Equipment is an ultrasonic diathermy device for use in applying therapeutic deep heat, classified under device class 2 and product code IMI. It is designed for physical medicine applications as indicated by its advisory committee designation and medical specialty description.

This device received FDA 510(k) clearance (K850640) on May 14, 1985, as substantially equivalent to a predicate device. It is manufactured by Fluidotherapy Corp. and is intended for use in clinical settings requiring therapeutic deep heat application, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions beyond what is explicitly stated in the data.

Other devices from Fluidotherapy Corp.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sonopuls 434 Ultrasound Therapy Equipment used for?

    The Sonopuls 434 is an ultrasonic diathermy device designed to apply therapeutic deep heat in physical medicine applications, as indicated by its advisory committee designation and medical specialty description.

  • How was the Sonopuls 434 cleared for market release?

    The Sonopuls 434 received FDA 510(k) clearance (K850640) on May 14, 1985, as substantially equivalent to a predicate device through a traditional review pathway.

  • Is the Sonopuls 434 supplied sterile or intended for single-use?

    The device data does not specify sterility, single-use, or reusable status; no claims are made regarding these attributes beyond what is explicitly stated in the documentation.