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510(k) K973096

NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM by Neotonus, Inc. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1998
Date Received
August 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Neotonus, Inc.

  • K002889 — PNS MAGNETIC STIMULATOR SYSTEM (April 6, 2001)
  • K001903 — NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (August 29, 2000)
  • K973929 — NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM (May 21, 1998)

Other clearances for product code KPI

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  • K251026 — Regenesis EMS Chair (August 29, 2025)
  • K243079 — NeuroTrac® MyoPlus Pro (MYO120U) (June 26, 2025)
  • K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) (March 27, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241899 — Pelvic Floor Stimulator (Intrelief PFE) (November 27, 2024)
  • K234061 — StarFormer (July 1, 2024)
  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)