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510(k) K033122

5000Z SYSTEM (OTC) by Prizm Medical, Inc. — Product Code NUH

Clearance Details

Decision
SESU ()
Decision Date
August 25, 2004
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Prizm Medical, Inc.

  • K133502 — 5000Z FIREFLY SYSTEM (December 3, 2014)
  • K032239 — THERA-CREAM, MODEL TCT004 (July 30, 2004)
  • K024181 — PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM (June 26, 2003)
  • K012974 — PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 (July 23, 2002)
  • K951727 — Z-WATCH SYSTEM (November 21, 1995)
  • K944487 — ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (February 21, 1995)
  • K932299 — ELECTRO-MESH (July 1, 1994)

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