ARCHGAUGE

by Archxerciser Corp.

510(k) K881024

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

510(k) K881024↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK881024	Date8 Apr 1988Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Archgauge(Tm)

510(k) Number: K881024
FDA Product Code: IPF

Device Class: Class II
Regulation: 21 CFR Part 890.5850
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ARCHGAUGE is a device classified under product code IPF, intended for physical medicine applications. It is designed to measure and assess physical parameters in a clinical setting.

The device is supplied by Archxerciser Corp. and received FDA 510(k) clearance on April 8, 1988. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.