Lower Body Cycles
FDA 510(k) K935061 · Biodex Medical Systems, Inc.
510(k) numberK935061
Submission
- Device name
- Lower Body Cycles
- Applicant
- Biodex Medical Systems, Inc.
Shirley, NY, US - Received
- October 21, 1993
- Decision date
- September 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336KPT · Traditional | 02/19/2009SE |
| K063666 | Sharps Container, Model 039-413MMK · Traditional | 01/25/2007SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | 11/16/1995SE |
| K950981 | Ultra-Pro Ultrasound Scanning Table Model #056-650IXR · Traditional | 04/03/1995SE |
| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302KHX · Traditional | 03/10/1995SE |
| K940301 | Compex 2IPF · Traditional | 12/28/1994SN |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | 09/16/1994SE |
Questions and answers
When was Lower Body Cycles cleared by the FDA?
Lower Body Cycles (K935061) received a 510(k) decision of Substantially Equivalent on September 16, 1994, 330 days after the submission was received.
What is the product code of K935061?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.