TE-800 Pelvic Floor Exerciser

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945937 ↗

FDA Product Code

HIR

Device Class

Class II

Regulation

21 CFR Part 884.1425

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Therapeutic Stimulator 300(Ts-300) & 300P(Ts-300P)

  Class II

  FDA 510(k) K932764 Active Cleared 1 Oct 1993

• Urogram Cystometrogram

  Class II

  FDA 510(k) K936041 Active Cleared 18 Apr 1994

• Uro-Gram Cystomrtrogram with Uroflowmetry

  Class II

  FDA 510(k) K944972 Active Cleared 8 Mar 1995

• Therapeutic Stimulator 2100 (Ts-2100)

  Class II

  FDA 510(k) K914904 Active Cleared 28 Apr 1992

• Neuromuscular Stimulator

  Class II

  FDA 510(k) K932611 Active Cleared 31 Jan 1994

• Ts-700P Control Xp Electrical Stimulator

  Class II

  FDA 510(k) K945292 Active Cleared 12 Apr 1995

See all devices from Myo/Kinetic Systems, Inc. →

• What is the TE-800 Pelvic Floor Exerciser used for?

  The TE-800 Pelvic Floor Exerciser is a perineometer designed to measure pelvic floor muscle strength, intended for use in obstetrics and gynecology applications as indicated by its medical specialty classification.

• What type of device is the TE-800 and how is it classified?

  The TE-800 is a perineometer, a device used to measure pelvic floor muscle strength, and is classified as a Class II medical device under regulation number 884.1425 with product code HIR.

• When did the TE-800 receive FDA clearance and what was the basis?

  The TE-800 received FDA 510(k) clearance (K945937) on July 14, 1995, and was found substantially equivalent to a predicate device through a traditional review process.