Sutter CPM 5000
FDA 510(k) K830974 · Sutter Biomedical, Inc.
510(k) numberK830974
Submission
- Device name
- Sutter CPM 5000
- Applicant
- Sutter Biomedical, Inc.
Mchenry, IL, US - Received
- March 28, 1983
- Decision date
- April 12, 1983
- 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 |
| K900794 | Mobilimb H3 Hand CPM UnitJFA · Traditional | Toronto Medical Corp. | 03/02/1990SE |
| 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 |
More from Danninger Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875249 | Sutter Phalangeal CapKWD · Traditional | 02/03/1988SE |
| K870200 | Sutter Finger Joint ProsthesisKYJ · Traditional | 10/09/1987SE |
| K861983 | Sutter Lesser Metatarsal CapKWD · Traditional | 09/08/1986SE |
| K850274 | Sutter CPM 9000 -Nonmeasuring Exercise EquipmentBXB · Traditional | 04/25/1985SE |
| K830649 | Sutter CPM 2000BXB · Traditional | 03/17/1983SE |
| K823539 | Sutter CPMBXB · Traditional | 01/14/1983SE |
| K820813 | Lesser Metatarsal Phalang. Joint ProsthKWH · Traditional | 05/21/1982SE |
| K820083 | Sutter CPMBXB · Traditional | 01/28/1982SE |
| K812691 | Silicone ImplantsMDM · Traditional | 11/16/1981SE |
| K802342 | Proximal Interphalangeal Joint ImplantJDI · Traditional | 10/14/1981SE |
Questions and answers
When was Sutter CPM 5000 cleared by the FDA?
Sutter CPM 5000 (K830974) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 15 days after the submission was received.
What is the product code of K830974?
The FDA product code is JFA – Exerciser, Finger, Powered, a Class I (low risk) device regulated under 21 CFR 890.5410.