KEGEL SMART, KEGELSMART PEARL— 510(k) K140780

Clearance details

Applicant

Regulatory Insight, Inc.

Product code

Code HIR

Device class

Class 2

Regulation

21 CFR 884.1425

Advisory panel

Obstetrics/Gynecology

Date received

2014-03-28

Decision date

2014-09-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Littleton, CO, US

• 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

• K112505 — ETHEREA2012-04-06
• K020094 — EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS2002-03-08
• K020100 — SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS2002-03-08