Patient Guided Knee Exerciser
FDA 510(k) K843493 · Richards Medical Co., Inc.
510(k) numberK843493
Submission
- Device name
- Patient Guided Knee Exerciser
- Applicant
- Richards Medical Co., Inc.
Mchenry, IL, US - Received
- September 6, 1984
- Decision date
- September 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K896106 | Rogozinski Spinal System, Add'L ComponentsKWP · Traditional | 06/25/1990SN |
| K900628 | Modular Hip SystemLZO · Traditional | 05/09/1990SN |
| K896580 | Uni-Polar HeadLZY · Traditional | 02/15/1990SE |
| K895241 | Intramedullary Hip ScrewKTT · Traditional | 01/04/1990SE |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | 11/21/1989SN |
| K896204 | Zirconia Ceramic Head Add'L SizesLZO · Traditional | 11/20/1989SN |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | 11/17/1989SE |
| K893377 | Russell-Taylor Intramedullary Knee Fusion NailsHSB · Traditional | 11/16/1989SE |
| K885069 | Zirconia Ceramic Head (Yitria Stabilized)LZO · Traditional | 09/01/1989SN |
| K892366 | Porous Genesis Stemmed Tibial ComponentJWH · Traditional | 07/19/1989SN |
Questions and answers
When was Patient Guided Knee Exerciser cleared by the FDA?
Patient Guided Knee Exerciser (K843493) received a 510(k) decision of Substantially Equivalent on September 12, 1984, 6 days after the submission was received.
What is the product code of K843493?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.