Sutter CPM 2000
FDA 510(k) K830649 · Sutter Biomedical, Inc.
510(k) numberK830649
Submission
- Device name
- Sutter CPM 2000
- Applicant
- Sutter Biomedical, Inc.
Walker, MI, US - Received
- March 1, 1983
- Decision date
- March 17, 1983
- 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 |
|---|---|---|
| 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 |
| K830974 | Sutter CPM 5000JFA · Traditional | 04/12/1983SE |
| 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 2000 cleared by the FDA?
Sutter CPM 2000 (K830649) received a 510(k) decision of Substantially Equivalent on March 17, 1983, 16 days after the submission was received.
What is the product code of K830649?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.