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A.R.M. (Aspen Return Monitor)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K873591

by Qmed, Inc.

Identifiers

510(k) Number
K873591 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The A.R.M. (Aspen Return Monitor) is a return electrode contact monitor designed to monitor the contact between a return electrode and the patient during electrosurgical procedures. It includes a transformer to isolate the oscillator from high RF voltages, as specified in its design.

The device is supplied as a reusable monitor and is intended for use in general and plastic surgery settings. It received FDA 510(k) clearance (K873591) on September 30, 1987, and is classified under product code GEI with advisory committee review in General and Plastic Surgery (SU).

Frequently asked questions

What is the A.R.M. (Aspen Return Monitor) used for?

The A.R.M. (Aspen Return Monitor) is designed to monitor the contact between a return electrode and the patient during electrosurgical procedures, ensuring proper electrode contact to prevent burns or ineffective current delivery.

Is the A.R.M. (Aspen Return Monitor) reusable or single-use?

The device is supplied as a reusable monitor, meaning it can be cleaned and used multiple times across procedures, as indicated in its description and specifications.

What safety feature does the A.R.M. (Aspen Return Monitor) include to protect against high voltages?

The A.R.M. includes a transformer to isolate the oscillator from high RF voltages, which is a specified design feature intended to enhance safety during electrosurgical use.

In which clinical settings is the A.R.M. (Aspen Return Monitor) intended for use?

The device is intended for use in general and plastic surgery settings, as stated in its description, reflecting its application in procedures requiring electrosurgical units with return electrode monitoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: A.r.m. (Aspen Return Monitor) - Beudamed, Qmed, Inc. FDA 510 (k) Products (1984-1998), Aspen Systems Inc | Medical Device Supplier Directory - qmed.com, Return electrode contact monitor - Aspen Laboratories, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Qmed, Inc.

Sources (1)

  • FDA 510(k) K873591 24 fields · synced Oct 6, 2026