Mobilimb L4 Lower Limb CPM Unit
FDA 510(k) K900795 · Toronto Medical Corp.
510(k) numberK900795
Submission
- Device name
- Mobilimb L4 Lower Limb CPM Unit
- Applicant
- Toronto Medical Corp.
Canada L1w2y5, CA - Received
- February 20, 1990
- Decision date
- March 12, 1990
- 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 |
|---|---|---|
| K950682 | W2 Wrist CPM UnitBXB · Traditional | 09/13/1995SE |
| K945121 | A3 Ankle CPM UnitBXB · Traditional | 02/17/1995SE |
| K935587 | Multilink Shoulder CPM UnitBXB · Traditional | 12/14/1994SE |
| K935841 | DR KoolILO · Traditional | 08/29/1994SN |
| K935808 | Revolution Lower Limb CPM UnitBXB · Traditional | 03/18/1994SE |
| K925926 | Mobilimb T1 Toe CPM UnitBXB · Traditional | 03/22/1993SE |
| K900466 | Mobilimb W1 Wrist CPM UnitBXB · Traditional | 03/12/1990SE |
| K900794 | Mobilimb H3 Hand CPM UnitJFA · Traditional | 03/02/1990SE |
| K895720 | Mobilimb J1 TMJ CPM UnitBXB · Traditional | 01/04/1990SE |
| K891345 | Mobilimb CPM Shoulder UnitBXB · Traditional | 04/24/1989SE |
Questions and answers
When was Mobilimb L4 Lower Limb CPM Unit cleared by the FDA?
Mobilimb L4 Lower Limb CPM Unit (K900795) received a 510(k) decision of Substantially Equivalent on March 12, 1990, 20 days after the submission was received.
What is the product code of K900795?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.