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510(k) K881753

ALPHA-STIM 350 by Electromedical Products, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
April 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Electromedical Products, Inc.

  • K903014 — ALPHA-STIM CS (May 12, 1992)
  • K896948 — ALPHA-STIM CS (February 23, 1990)
  • K831145 — ALPHA-STIM 350 (July 7, 1983)
  • K831144 — ALPHA-STIM 2000 (June 30, 1983)

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