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510(k) K011913

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES by Sun-Rain System Corp. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2001
Date Received
June 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Sun-Rain System Corp.

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  • K024013 — SUN-RAIN ULTRASONIC THERAPY, SU-100 (October 31, 2003)

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