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510(k) K024013

SUN-RAIN ULTRASONIC THERAPY, SU-100 by Sun-Rain System Corp. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2003
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Sun-Rain System Corp.

  • K090542 — SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-8 (October 23, 2009)
  • K011913 — SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES (October 26, 2001)

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