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510(k) K120093

BTL ELITE by BTL Industries, Inc. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2012
Date Received
January 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances by BTL Industries, Inc.

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  • K242532 — BTL-785BNF-E (December 13, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K230657 — BTL-99-OC (February 1, 2024)

Other clearances for product code IMJ

  • K250376 — ViVY (November 5, 2025)
  • K243112 — Curapuls 670 (June 25, 2025)
  • K223620 — Reprieve by RegenesisTM (May 24, 2023)
  • K182363 — BTL-703 (January 24, 2019)
  • K173300 — ViaTherm BOOST (May 1, 2018)
  • K162240 — ProMedTek Model C1400 Shortwave Diathermy Device (November 17, 2016)
  • K161862 — ThermoPro (November 14, 2016)
  • K153456 — Megapulse III Shortwave Diathermy (June 14, 2016)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131899 — SW-THERM (March 14, 2014)