Computerized Testing and Exercise Systems
FDA 510(k) K926313 · Henley Intl.
510(k) numberK926313
Submission
- Device name
- Computerized Testing and Exercise Systems
- Applicant
- Henley Intl.
Sugar Land, TX, US - Received
- December 15, 1992
- Decision date
- February 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BXB – Exerciser, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code BXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072887 | G-Trainer MedicalBXB · Traditional | Alter-G, Inc. | 01/25/2008SE |
| K003272 | Flo-BootBXB · Traditional | Discovery Group, LLC | 04/04/2001SE |
| K952975 | Ankle Calf Exerciser PhlebopumpBXB · Traditional | Prevent Products, Inc. | 09/25/1996SE |
| K953456 | E-Z FlexBXB · Traditional | Fluid Motion Biotechnologies, Inc. | 01/26/1996SE |
| K955106 | Bte CPM-20BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K951028 | Hamex TwoBXB · Traditional | Northern Orthopaedic Products, Inc. | 12/11/1995SE |
| K950755 | Flexmate K500BXB · Traditional | Breg, Inc. | 10/05/1995SE |
| K951029 | Hamex OneBXB · Traditional | Northern Orthopaedic Products, Inc. | 09/15/1995SE |
| K945733 | Aquahab, Model 120-72-101BXB · Traditional | Aquarius Electronics, Inc. | 09/15/1995SE |
More from Aquarius Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943449 | Neurological Diagnostic DevicesGXY · Traditional | 11/15/1995SE |
| K926279 | Upper Body ExerciserISD · Traditional | 05/05/1994SE |
| K926278 | Stair ClimberISD · Traditional | 05/05/1994SE |
| K926287 | Exercise BicycleISD · Traditional | 03/22/1994SE |
| K926314 | Hydra Fitness Model 311 Total PowerISD · Traditional | 03/18/1994SE |
| K915864 | Monotrode Cutaneous ElectrodeGXY · Traditional | 07/21/1993SE |
| K922036 | Sonopuls 591IMG · Traditional | 06/29/1993SE |
| K926316 | True-Trac, StratusJFB · Traditional | 03/24/1993SE |
| K920983 | Sonopuls 590IMI · Traditional | 03/09/1993SE |
| K922020 | Endomed 582LIH · Traditional | 09/22/1992SE |
Questions and answers
When was Computerized Testing and Exercise Systems cleared by the FDA?
Computerized Testing and Exercise Systems (K926313) received a 510(k) decision of Substantially Equivalent on February 4, 1994, 416 days after the submission was received.
What is the product code of K926313?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.