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510(k) K914904

THERAPEUTIC STIMULATOR 2100 (TS-2100) by Myo/Kinetic Systems, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1992
Date Received
November 1, 1991
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 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)
  • K932611 — NEUROMUSCULAR STIMULATOR (January 31, 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)

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