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510(k) K932399

THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) by Myo/Kinetic Systems, Inc. — Product Code IPF

K932399 is an FDA 510(k) premarket notification submitted by Myo/Kinetic Systems, Inc. for the device "THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)". The FDA issued a decision of Substantially Equivalent on August 11, 1993. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Myo/Kinetic Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1993
Date Received
May 18, 1993
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)
  • K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100) (April 28, 1992)

Other clearances for product code IPF

  • K253542 — Apollo Quattro (APQ-10M) (June 8, 2026)
  • K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) (June 2, 2026)
  • K260142 — StimelMD (SSMD) system (May 27, 2026)
  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • 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)

FDA data resources