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510(k) K951727

Z-WATCH SYSTEM by Prizm Medical, Inc. — Product Code IPF

Clearance Details

Decision
SN ()
Decision Date
November 21, 1995
Date Received
April 13, 1995
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 Prizm Medical, Inc.

  • K133502 — 5000Z FIREFLY SYSTEM (December 3, 2014)
  • K033122 — 5000Z SYSTEM (OTC) (August 25, 2004)
  • 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)
  • K944487 — ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (February 21, 1995)
  • K932299 — ELECTRO-MESH (July 1, 1994)

Other clearances for product code IPF

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  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)