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510(k) K202337

Pulsed electromagnetic field wrap by Hi-Dow International, Inc. — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2020
Date Received
August 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Hi-Dow International, Inc.

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  • K190617 — Wrap accessory electrodes (July 2, 2019)
  • K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N) (August 4, 2017)
  • K102598 — HI-DOW-XP (May 13, 2011)

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  • K121338 — ZEOBI (July 27, 2012)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)
  • K092044 — ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (December 18, 2009)
  • K091996 — ORTHOCOR KNEE SYSTEM BASIC (December 15, 2009)
  • K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (December 11, 2008)
  • K070931 — MODEL PMT850 (May 24, 2007)