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510(k) K032793

US-100 PORTABLE ULTRASOUND THERAPY UNIT by Ito Co., Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
September 9, 2003
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

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  • K992545 — TM-300 TRACTION SYSTEM (September 1, 1999)

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