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Portable Pulse Galvanic Stimulator

by Staodynamics, Inc.

510(k) K791087

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 NumberK791087 Date12 Oct 1979ClearedStatusActive

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  • Withdrawn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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Portable Pulse Galvanic Stimulator is a Stimulator, Muscle, Powered (per FDA classification IPF) designed to deliver electrical stimulation for muscle activation and rehabilitation. It operates via galvanic pulses to facilitate neuromuscular activity, aiding in physical therapy and pain management applications within physical medicine. The device is intended for controlled electrical stimulation of skeletal muscles, supporting recovery and mobility.

This device is supplied as a reusable, non-sterile medical instrument, intended for use in clinical or home settings under professional supervision. It is classified as a Class II device under FDA regulations (890.5850) and holds a FDA 510(k) clearance (K791087) with a Substantially Equivalent determination. No specific MRI safety or sterility requirements are noted in the regulatory data, and its operation relies on battery-powered pulse generation. Storage conditions are not detailed in the submission.

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Questions

AI-generated answers, 1 Oct 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 Portable Pulse Galvanic Stimulator used for?

    The Portable Pulse Galvanic Stimulator is designed to deliver controlled electrical stimulation to skeletal muscles, aiding in muscle activation, rehabilitation, and pain management. It is particularly useful in physical therapy settings to support recovery and improve mobility by facilitating neuromuscular activity through galvanic pulses.

  • Is the Portable Pulse Galvanic Stimulator reusable or single-use?

    The Portable Pulse Galvanic Stimulator is supplied as a reusable device, intended for repeated use in clinical or home settings. It is not classified as single-use, but it should be operated under professional supervision to ensure proper application and maintenance.

  • What are the storage requirements for this device?

    The regulatory data for the Portable Pulse Galvanic Stimulator does not specify detailed storage conditions. However, as a battery-powered device, it should be stored in a dry environment away from extreme temperatures to preserve functionality and battery life.

  • Can this device be used safely in an MRI environment?

    The regulatory submission for the Portable Pulse Galvanic Stimulator does not provide explicit information regarding MRI safety. Users should consult the manufacturer’s guidelines or technical documentation to ensure compatibility and safety before using the device in an MRI setting.

  • How is the Portable Pulse Galvanic Stimulator powered?

    The Portable Pulse Galvanic Stimulator operates using battery-powered pulse generation. This design allows for portability, enabling use in both clinical and home environments without the need for direct electrical outlets.