Myo/Kinetic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Myo/Kinetic Systems, Inc. makes
Myo/Kinetic Systems, Inc. manufactures therapeutic electrical stimulators, including neuromuscular and pelvic floor exercisers, for clinical and home use. Their portfolio includes devices for cystometry and urodynamic testing, such as cystometrograms with and without uroflowmetry. Additional offerings include specialized stimulators for therapeutic applications, designed to support musculoskeletal and urological rehabilitation.
The company’s devices are classified as Class II under FDA regulations, requiring 510(k) clearance for market authorisation. These products are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Te-800 Pelvic Floor Exerciser Ref K945937
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Urogram Cystometrogram Ref K936041
Regimes: 510(k) Registry: 510(k)Uro-Gram Cystomrtrogram With Uroflowmetry Ref K944972
Regimes: 510(k) Registry: 510(k)Therapeutic Stimulator 2100 (Ts-2100) Ref K914904
Regimes: 510(k) Registry: 510(k)Neuromuscular Stimulator Ref K932611
Regimes: 510(k) Registry: 510(k)Ts-700P Control Xp Electrical Stimulator Ref K945292
Regimes: 510(k) Registry: 510(k)Therapeutic Stim 200 (Ts-200)/200P (Ts-200P) Ref K932399
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Myo/Kinetic Systems, Inc. have in the registry?
The registry currently lists 8 devices for Myo/Kinetic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Myo/Kinetic Systems, Inc.'s devices?
Among its 8 most recently registered devices, Myo/Kinetic Systems, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Myo/Kinetic Systems, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Myo/Kinetic Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Myo/Kinetic Systems, Inc. in the registry?
The most recently registered devices listed for Myo/Kinetic Systems, Inc. include TE-800 PELVIC FLOOR EXERCISER, THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P), UROGRAM CYSTOMETROGRAM and URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY.