ELECTRO-MYOGRAPHIC PERINEOMETER— 510(k) K854193

Name: FDA 510(k) clearance K854193
Creator: U.S. Food and Drug Administration
Published: 1986-06-09

Substantially Equivalent

Verimed Holdings, Inc.

FDA 510(k) clearance K854193 for ELECTRO-MYOGRAPHIC PERINEOMETER, Substantially Equivalent on 1986-06-09. Applicant: Verimed Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Verimed Holdings, Inc.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1985-10-15
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIR

view all

K252748 — Pelvic Floor Exerciser (PF01)2026-04-27
K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)2024-08-01
K231875 — Vaginal Tactile Ultrasound Imager2024-02-22
K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)2023-12-29
K231780 — Perifit Care+2023-12-20

More clearances from Verimed Holdings, Inc.

view all

K981277 — PERIFORM1998-11-20
K954127 — BIOFEEDBACK DEVICE1995-11-14
K951969 — MYOEXORCISER II FUAL1995-06-14
K930670 — PHYACTION 7871993-07-02
K922550 — ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)1992-12-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.