PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000— 510(k) K001515
Substantially EquivalentThe Prometheus Group
FDA 510(k) clearance K001515 for PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000, Substantially Equivalent on 2000-07-31. Applicant: The Prometheus Group. Device class: 2.
Clearance details
- Applicant
- The Prometheus Group
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duxbury, MA, US
Recent devices under product code KPI
view all- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from The Prometheus Group
view all- K160792 — Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
- K030039 — PATHWAY STM-10 PELVIC FLOOR STIMULATOR
- K023906 — PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
- K993976 — PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
- K974036 — PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.