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Neurodyn Compact, Neurodyn II

by Ibramed Equipamentos Médicos

510(k) K131917

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 NumberK131917 Date29 Apr 2014ClearedStatusActive

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  • Withdrawn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
FDA applicant
Ibramed Equipamentos Medicos
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Neurodyn Compact and Neurodyn II are transcutaneous neuromuscular stimulators designed for physical rehabilitation. These devices deliver electrical stimulation via two independent output channels, enabling targeted treatment of muscle dysfunction or pain through TENS, FES, or Russian current modalities.

Supplied as a portable, two-channel stimulator, the Neurodyn Compact and Neurodyn II are intended for clinical use under prescription. Each channel features individual intensity control, and the device is classified under the FDA’s Physical Medicine category with a Traditional 510(k) clearance (K131917). No sterility or single-use designation is specified, and MRI safety is not addressed in the data.

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