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Shortwave Diathermy Model 802

by Birtcher Corp. 510(k)

Active United States

510(k) K780755

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780755 Date12 May 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IMJ
Device Class
Class II
Regulation
21 CFR Part 890.5290
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Shortwave Diathermy Model 802 is a Class II medical device classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat. It is designed to deliver therapeutic deep heat for physical medicine applications.

The device is manufactured by Birtcher Corp. and received FDA 510(k) clearance on May 12, 1978. It is authorized for use in physical medicine settings and is subject to special controls. The device is supplied with various model numbers and registration numbers as specified in the authorizations.

Other devices from Birtcher Corp.

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Questions

AI-generated answers, 28 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 Shortwave Diathermy Model 802 used for?

    The Shortwave Diathermy Model 802 is designed to deliver therapeutic deep heat for physical medicine applications. It is classified as a Class II medical device specifically for applying therapeutic deep heat in physical medicine settings.

  • Is the Shortwave Diathermy Model 802 a single-use or reusable device?

    The device information does not specify whether the Shortwave Diathermy Model 802 is single-use or reusable. As a therapeutic medical device, it is likely designed for multiple patient applications following proper sterilization procedures between uses.

  • What regulatory approvals does the Shortwave Diathermy Model 802 have?

    The Shortwave Diathermy Model 802 received FDA 510(k) clearance on May 12, 1978. It is classified as a Class II medical device and is subject to special controls for physical medicine applications.

  • How is the Shortwave Diathermy Model 802 supplied?

    The device is supplied with various model numbers and registration numbers as specified in the authorizations. The manufacturer is Birtcher Corp., located in McHenry, IL, and the device is distributed for use in physical medicine settings.