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MyoSystem With Customizing

by Otto Bock HealthCare LP

510(k) K032833

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032833 Date23 Sep 2003ClearedStatusActive

Official records

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  • Withdrawn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
GXY
Device class
Class II
Regulation
21 CFR Part 882.1320
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 MyoSystem With Customizing is a cutaneous electrode designed for neuromuscular electrical stimulation (NMES) applications in neurology. It facilitates functional muscle activation and rehabilitation by delivering targeted electrical impulses to stimulate weakened or paralyzed muscles, aiding in mobility and recovery for patients with neurological conditions.

This device is intended for single-use and is supplied sterile, adhering to regulatory standards for Class II medical devices under 21 CFR 882.1320. It is intended for use in clinical settings, including physical therapy and rehabilitation facilities, and requires proper storage as per manufacturer guidelines. The device holds FDA 510(k) clearance (K032833) and is classified under product code GXY for neuromuscular applications.

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

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