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Port-O-Heat, Model 0100

by Arthotronics, Inc.

510(k) K882151

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 NumberK882151 Date4 Nov 1988ClearedStatusActive

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  • Withdrawn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
IRT
Device Class
Class II
Regulation
21 CFR Part 890.5740
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 PORT-O-HEAT, MODEL 0100 is a medical device classified under Physical Medicine, intended for use in the field of physical medicine and rehabilitation. It is designed to provide therapeutic heat applications, which are commonly used to alleviate pain and promote healing in musculoskeletal conditions.

The device is supplied as a single-use item and is intended for use by healthcare professionals. It is not specified as reusable, and its storage requirements are not detailed in the provided data. The device has received authorization from the FDA under a 510(k) submission, with a decision of Substantially Equivalent.

Questions

AI-generated answers, 23 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 PORT-O-HEAT, MODEL 0100 used for?

    This device is intended for therapeutic heat applications in the field of physical medicine and rehabilitation to alleviate pain and promote healing in musculoskeletal conditions.

  • Is the PORT-O-HEAT, MODEL 0100 reusable?

    No, the device is supplied as a single-use item and is not specified as reusable.

  • How is the PORT-O-HEAT, MODEL 0100 authorized for use?

    The device has received authorization from the FDA under a 510(k) submission, with a decision of Substantially Equivalent.