Mobilimb H3 Hand CPM Unit
FDA 510(k) K900794 · Toronto Medical Corp.
510(k) numberK900794
Submission
- Device name
- Mobilimb H3 Hand CPM Unit
- Applicant
- Toronto Medical Corp.
Canada L1w2y5, CA - Received
- February 20, 1990
- Decision date
- March 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFA – Exerciser, Finger, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5410
- Specialty
- Physical Medicine
Other 510(k)s with product code JFA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945803 | Thermaflex, Model SD 55 C.P.M.H.JFA · Traditional | Burke Neutech, Inc. | 05/11/1995SE |
| K931016 | Jace Model H440 Hand CPM DeviceJFA · Traditional | Jace Systems, Inc. | 06/22/1994SE |
| K933418 | Hand Therapy AssostJFA · Traditional | Bardon Ent., Inc. | 04/28/1994SE |
| K921351 | Jace Model PM-410 Hand CPM DeviceJFA · Traditional | Jace Systems, Inc. | 05/04/1992SE |
| K900581 | Danniflex CPM 880(TM)JFA · Traditional | Buckman Co., Inc. | 02/20/1990SE |
| K880686 | Toronto/Mobilimb Hand C.P.M.JFA · Traditional | Toronto Medical Corp. | 02/26/1988SE |
| K880336 | Mobilimb Hand C.P.M. UnitJFA · Traditional | Toronto Medical Corp. | 02/16/1988SE |
| K860714 | Ace Aim - CPM Hand UnitJFA · Traditional | Buckman Co., Inc. | 03/27/1986SE |
| K844033 | Mobilimb Hand UnitJFA · Traditional | Danninger Medical Technology, Inc. | 11/27/1984SE |
| K830974 | Sutter CPM 5000JFA · Traditional | Sutter Biomedical, Inc. | 04/12/1983SE |
More from Sutter Biomedical, 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 |
| K900795 | Mobilimb L4 Lower Limb CPM UnitBXB · Traditional | 03/12/1990SE |
| K900466 | Mobilimb W1 Wrist CPM UnitBXB · Traditional | 03/12/1990SE |
| 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 H3 Hand CPM Unit cleared by the FDA?
Mobilimb H3 Hand CPM Unit (K900794) received a 510(k) decision of Substantially Equivalent on March 2, 1990, 10 days after the submission was received.
What is the product code of K900794?
The FDA product code is JFA – Exerciser, Finger, Powered, a Class I (low risk) device regulated under 21 CFR 890.5410.