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STEALTH

by The Buzzz Corp.

510(k) K972036

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 NumberK972036 Date3 Jul 1997ClearedStatusActive

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  • Withdrawn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
INI
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 STEALTH is a Class 2 Physical Medicine device with product code INI. It is a motorized 3-wheeled vehicle designed for physical medicine applications.

The device is manufactured by The Buzzz Corp. and received FDA 510(k) clearance on July 3, 1997, with the K number K972036. It is substantially equivalent to predicate devices and is regulated under product code INI.

Other devices from The Buzzz Corp.

  • Prowler

    Class II

  • Prevent I

    Class II

  • Intruder

    Class II

Questions

AI-generated answers, 24 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 STEALTH device used for?

    The STEALTH is a Class 2 Physical Medicine device designed for physical medicine applications. It is a motorized 3-wheeled vehicle that serves specific therapeutic purposes in physical medicine settings.

  • Is the STEATH device single-use or reusable?

    The device data does not specify whether the STEALTH is designed for single-use or multiple uses. This information would typically be found in the device's instructions for use or labeling materials.

  • What regulatory approvals does the STEALTH have?

    The STEALTH received FDA 510(k) clearance on July 3, 1997, with K number K972036. It is classified as a Class 2 device under product code INI and is considered substantially equivalent to predicate devices.

  • Who manufactures the STEALTH device?

    The STEALTH device is manufactured by The Buzzz Corp., located at 213 E. Luzerne Ave., Larksville, PA 18704. The company received FDA clearance for this device in 1997.