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510(k) K153456

Megapulse III Shortwave Diathermy by Accelerated Care Plus — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2016
Date Received
December 1, 2015
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 Accelerated Care Plus

  • K093600 — OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM (December 4, 2009)
  • K060191 — ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT (July 12, 2006)

Other clearances for product code IMJ

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  • 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)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131899 — SW-THERM (March 14, 2014)
  • K121123 — BIOFUSIONARY BEBE (March 10, 2014)