# Henley Intl.

- Location (FDA's records): Sugar Land, TX
- FDA decisions: 44 (1986–1995): 44 510(k) clearances
- Product codes: GZJ (10), GXY (4), ISD (4), IMG (3), IPF (3), LSB (2), IMI (2), KKX (2), GYB (2), IMF (2), LIH (2), IMJ (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Thermo-Electric Co.: 2 (https://510kreport.com/company/thermo-electric)
- Mettler Electronics Corp.: 1 (https://510kreport.com/company/mettler-electronics)
- Enraf-Nonius, B.V.: 1 (https://510kreport.com/company/enraf-nonius)

## Its most-cited devices
- K871802: Model K210 and K211 Fluidotherapy Units (1987), cited by 1
- K880699: Endomed CV405 (1988), cited by 1
- K861248: Curapuls 419 Diathermy Unit (1986), cited by 1
- K896817: Model T11 Fluidotherapy Unit (1991), cited by 1

## Recent decisions
- K943449: Neurological Diagnostic Devices (Nov 15, 1995)
- K926278: Stair Climber (May 5, 1994)
- K926279: Upper Body Exerciser (May 5, 1994)
- K926287: Exercise Bicycle (Mar 22, 1994)
- K926314: Hydra Fitness Model 311 Total Power (Mar 18, 1994)
- K926313: Computerized Testing and Exercise Systems (Feb 4, 1994)
- K915864: Monotrode Cutaneous Electrode (Jul 21, 1993)
- K922036: Sonopuls 591 (Jun 29, 1993)

Source page: https://510kreport.com/company/henley-intl