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Parastep-I Functional Walking Neuromuscular Stimulator

by Sigmedics, Inc.

PMA P900038

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P900038↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP900038 Date20 Apr 1994ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Parastep-I
Generic Name
Stimulator, functional walking neuromuscular, non-invasive
PMA Number
FDA Product Code
MKD
Device Class
Class III
Advisory Committee
Neurology
FDA Decision
APPR Approved

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 Parastep-I is a non-invasive functional walking neuromuscular stimulator, classified as a Class III device under the FDA’s medical device nomenclature. It is designed to restore or improve walking function by electrically stimulating nerves and muscles in patients with neurological impairments, such as spinal cord injuries or stroke-related paralysis.

This device is supplied as a reusable system and requires FDA Premarket Approval (PMA P900038) for use. It is intended for clinical settings, including rehabilitation facilities, and must be operated by trained personnel following manufacturer instructions. The device is not MRI-safe and should be stored in a clean, dry environment to maintain functionality and sterility.

Questions

AI-generated answers, 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.

  • What is the Parastep-I device used for?

    The Parastep-I is a non-invasive functional walking neuromuscular stimulator designed to restore or improve walking function by electrically stimulating nerves and muscles in patients with neurological impairments such as spinal cord injuries or stroke-related paralysis.

  • How is the Parastep-I supplied and what are its usage requirements?

    The Parastep-I is supplied as a reusable system that requires FDA Premarket Approval (PMA P900038). It is intended for clinical settings including rehabilitation facilities and must be operated by trained personnel following manufacturer instructions.

  • Is the Parastep-I MRI-safe and how should it be stored?

    The Parastep-I is not MRI-safe and should be stored in a clean, dry environment to maintain functionality and sterility.

  • What is the regulatory classification of the Parastep-I device?

    The Parastep-I is classified as a Class III device under the FDA's medical device nomenclature and has received FDA Premarket Approval (PMA P900038) for use.