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510(k) K932611

NEUROMUSCULAR STIMULATOR by Myo/Kinetic Systems, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
May 28, 1993
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 Myo/Kinetic Systems, Inc.

  • K945937 — TE-800 PELVIC FLOOR EXERCISER (July 14, 1995)
  • K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR (April 12, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K936041 — UROGRAM CYSTOMETROGRAM (April 18, 1994)
  • K932764 — THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) (October 1, 1993)
  • K932399 — THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) (August 11, 1993)
  • K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100) (April 28, 1992)

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