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Special Electromagnetic Therapeutic Apparatus

by China Chongqing Bashan Instrument Factory

510(k) K963728

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 NumberK963728 Date12 Dec 1996ClearedStatusActive

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  • Withdrawn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)

Full name
The Special Electromagnetic Therapeutic Apparatus
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 Special Electromagnetic Therapeutic Apparatus is classified as a Lamp, Infrared, Therapeutic Heating, designed for physical medicine applications. It delivers electromagnetic energy in the infrared spectrum to provide therapeutic heating for musculoskeletal or soft tissue conditions. The device operates under the regulatory framework for Class II devices with special controls, ensuring compliance with safety and performance standards for electromagnetic therapeutic equipment.

This apparatus is intended for single-use or reusable settings, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K963728) with a Substantially Equivalent (SESE) determination. It falls under the Physical Medicine advisory committee category and is exempt from certain premarket notification procedures under § 890.9 when used as an infrared therapeutic heating lamp. Storage and handling must adhere to manufacturer instructions to maintain efficacy and safety.

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 Special Electromagnetic Therapeutic Apparatus used for?

    This device is designed for physical medicine applications, specifically delivering infrared electromagnetic energy to provide therapeutic heating. It targets musculoskeletal or soft tissue conditions, helping alleviate pain, reduce inflammation, or improve tissue repair through controlled heat therapy.

  • Is this device single-use or reusable?

    The device can be used in either single-use or reusable settings, depending on the manufacturer’s guidelines. Proper cleaning, disinfection, and maintenance procedures must be followed if reused to ensure safety and efficacy, as outlined in the manufacturer’s instructions.

  • What regulatory classification and clearance does this device hold?

    The Special Electromagnetic Therapeutic Apparatus is classified as a Class II device under FDA regulations with special controls. It holds a Substantially Equivalent (SESE) determination (K963728) through a traditional 510(k) clearance process, ensuring compliance with safety and performance standards for electromagnetic therapeutic equipment.

  • How should this device be stored to maintain its effectiveness?

    Storage and handling must strictly follow the manufacturer’s instructions to preserve the device’s functionality and safety. This includes protecting it from moisture, extreme temperatures, and physical damage, as well as ensuring proper packaging if single-use units are involved.

  • What advisory committee oversees this device’s regulatory review?

    This device falls under the Physical Medicine (PM) advisory committee category during its regulatory review process. The committee provides expert guidance on its safety, performance, and intended use within the broader scope of physical medicine devices.