UPPER BODY EXERCISER— 510(k) K926279

Name: FDA 510(k) clearance K926279
Creator: U.S. Food and Drug Administration
Published: 1994-05-05

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K926279 for UPPER BODY EXERCISER, Substantially Equivalent on 1994-05-05. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1992-12-14
Decision date: 1994-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISD

view all

K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra2020-12-21
K183296 — REAL Immersive System2019-03-18
K143512 — ActiSpec Activity Monitor2015-08-26
K112121 — ERGOSELECT/GE2012-10-31
K080545 — ACTITRAINER2008-07-24

More clearances from Henley Intl.

view all

K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES1995-11-15
K926278 — STAIR CLIMBER1994-05-05
K926287 — EXERCISE BICYCLE1994-03-22
K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER1994-03-18
K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS1994-02-04

Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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