COMPUTERIZED TESTING AND EXERCISE SYSTEMS— 510(k) K926313

Name: FDA 510(k) clearance K926313
Creator: U.S. Food and Drug Administration
Published: 1994-02-04

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K926313 for COMPUTERIZED TESTING AND EXERCISE SYSTEMS, Substantially Equivalent on 1994-02-04. Applicant: Henley Intl.. Device class: 1.

Clearance details

Applicant: Henley Intl.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1992-12-15
Decision date: 1994-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BXB

view all

K072887 — G-TRAINER MEDICAL2008-01-25
K003272 — FLO-BOOT2001-04-04
K952975 — ANKLE CALF EXERCISER PHLEBOPUMP1996-09-25
K953456 — E-Z FLEX1996-01-26
K955105 — BTE CPM-101995-12-29

More clearances from Henley Intl.

view all

K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES1995-11-15
K926278 — STAIR CLIMBER1994-05-05
K926279 — UPPER BODY EXERCISER1994-05-05
K926287 — EXERCISE BICYCLE1994-03-22
K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER1994-03-18

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