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Nerve Stimulator Model AA 1050

by Anesthesia Assoc., Inc.

510(k) K811614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811614 Date18 Jun 1981ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BXN
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
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 Nerve Stimulator Model AA 1050 is a battery-powered device classified as a nerve stimulator. It is designed to facilitate nerve conduction testing and stimulation during medical procedures, particularly in anesthesiology, to assess peripheral nerve function and aid in nerve block placement or monitoring.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K811614) with a classification of Class II. It operates under regulation 868.2775 and is intended for use in clinical settings where precise nerve stimulation is required. The device is not described as single-use or MRI-safe in the available data.

Other devices from Anesthesia Assoc., Inc.

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 primary use of the Nerve Stimulator Model AA 1050?

    The Nerve Stimulator Model AA 1050 is designed for nerve conduction testing and stimulation during medical procedures, particularly in anesthesiology. It helps assess peripheral nerve function and aids in nerve block placement or monitoring, ensuring accurate nerve localization and response evaluation.

  • Is the Nerve Stimulator Model AA 1050 single-use or reusable?

    The Nerve Stimulator Model AA 1050 is supplied as a reusable medical instrument. This classification aligns with its intended clinical use, where durability and repeated use in sterile environments are essential for reliable nerve stimulation and testing.

  • What regulatory pathway does the Nerve Stimulator Model AA 1050 follow?

    The Nerve Stimulator Model AA 1050 is regulated under the FDA 510(k) clearance process, specifically with clearance number K811614. It falls under the classification of Class II medical devices and is governed by regulation 868.2775, ensuring compliance with safety and performance standards for nerve stimulators.

  • Does the Nerve Stimulator Model AA 1050 include any special safety features or limitations?

    The available data does not specify whether the Nerve Stimulator Model AA 1050 is MRI-safe or includes additional safety features beyond its core functionality. Clinicians should follow standard safety protocols for nerve stimulation, including proper grounding and patient monitoring, to ensure safe operation.

  • What medical specialties primarily utilize the Nerve Stimulator Model AA 1050?

    The Nerve Stimulator Model AA 1050 is primarily intended for use in anesthesiology, where precise nerve stimulation is critical for procedures such as regional anesthesia, nerve blocks, and monitoring nerve integrity during surgical interventions.