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Infrared Hex

by Healthteam

510(k) K890585

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 NumberK890585 Date22 Aug 1989ClearedStatusActive

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  • Withdrawn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
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
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 Infrared Hex is a handheld infrared heat therapy device, classified as a physical medicine instrument. It delivers localized infrared radiation to promote tissue warming and pain relief, commonly used in musculoskeletal therapy.

This device is supplied as a reusable, non-sterile unit designed for clinical or home use. It operates on standard 110V AC power and features adjustable settings (High/Low/Off). Cleared under FDA 510(k) K890585 with a Traditional review pathway, it falls under product code ILY and was determined substantially equivalent to a predicate device in 1989.

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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 Infrared Hex device used for?

    The Infrared Hex is a handheld infrared heat therapy device designed to deliver localized infrared radiation for tissue warming. This promotes pain relief, particularly in musculoskeletal therapy, by improving blood circulation and reducing stiffness in targeted areas.

  • Is the Infrared Hex device reusable or single-use?

    The Infrared Hex is supplied as a reusable unit, meaning it is intended for repeated use in clinical or home settings. It is not sterile, so proper cleaning and maintenance are required between uses to ensure hygiene and functionality.

  • What power source and settings does the Infrared Hex use?

    The Infrared Hex operates on standard 110V AC power and includes adjustable settings for High, Low, and Off. These settings allow users to control the intensity of the infrared radiation based on their specific therapeutic needs.

  • How is the Infrared Hex device cleared for use?

    The Infrared Hex received FDA 510(k) clearance under the Traditional review pathway, with clearance number K890585. It was determined substantially equivalent to a predicate device in 1989 and falls under product code ILY for physical medicine instruments.

  • What are the key specifications for storage and maintenance?

    Since the Infrared Hex is a reusable, non-sterile device, it requires proper cleaning and maintenance between uses to prevent contamination and ensure optimal performance. Users should follow manufacturer guidelines for cleaning and storage to extend the device’s lifespan and maintain its effectiveness.