SUTTER CPM 5000
FDA 510(k) clearance K830974 · decided 1983-04-12
Clearance details
- K-number
- K830974
- Device name
- SUTTER CPM 5000
- Applicant
- Sutter Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-28
- Decision date
- 1983-04-12
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JFA
- Device class
- 1
- Regulation number
- 890.5410
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMAFLEX, MODEL SD 55 C.P.M.H. (K945803) | Burke Neutech, Inc. | 1995-05-11 |
| JACE MODEL H440 HAND CPM DEVICE (K931016) | Jace Systems, Inc. | 1994-06-22 |
| HAND THERAPY ASSOST (K933418) | Bardon Ent., Inc. | 1994-04-28 |
| JACE MODEL PM-410 HAND CPM DEVICE (K921351) | Jace Systems, Inc. | 1992-05-04 |
| MOBILIMB H3 HAND CPM UNIT (K900794) | Toronto Medical Corp. | 1990-03-02 |
| DANNIFLEX CPM 880(TM) (K900581) | Buckman Co., Inc. | 1990-02-20 |
| TORONTO/MOBILIMB HAND C.P.M. (K880686) | Toronto Medical Corp. | 1988-02-26 |
| MOBILIMB HAND C.P.M. UNIT (K880336) | Toronto Medical Corp. | 1988-02-16 |
| ACE AIM - CPM HAND UNIT (K860714) | Buckman Co., Inc. | 1986-03-27 |
| MOBILIMB HAND UNIT (K844033) | Danninger Medical Technology, Inc. | 1984-11-27 |
| BURNETT-KETCHUM DYNAMIC HAND EXERCISER (K790527) | Maddak, Inc. | 1979-03-22 |
Recalls involving this device
No recalls on record reference this clearance.