JFA · Exerciser, Finger, Powered
Physical Medicine · 21 CFR 890.5410 · Class 1
Overview
| Product Code | JFA |
|---|---|
| Device Name | Exerciser, Finger, Powered |
| Regulation | 21 CFR 890.5410 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | Burke Neutech, Inc. | May 11, 1995 | SESE |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | Jace Systems, Inc. | Jun 22, 1994 | SESE |
| K933418 | HAND THERAPY ASSOST | Bardon Ent., Inc. | Apr 28, 1994 | SESE |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | Jace Systems, Inc. | May 4, 1992 | SESE |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Toronto Medical Corp. | Mar 2, 1990 | SESE |
| K900581 | DANNIFLEX CPM 880(TM) | Buckman Co., Inc. | Feb 20, 1990 | SESE |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | Feb 26, 1988 | SESE |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | Feb 16, 1988 | SESE |
| K860714 | ACE AIM - CPM HAND UNIT | Buckman Co., Inc. | Mar 27, 1986 | SESE |
| K844033 | MOBILIMB HAND UNIT | Danninger Medical Technology, Inc. | Nov 27, 1984 | SESE |
| K830974 | SUTTER CPM 5000 | Sutter Biomedical, Inc. | Apr 12, 1983 | SESE |
| K790527 | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Maddak, Inc. | Mar 22, 1979 | SESE |
Top Applicants
- Toronto Medical Corp. — 3 clearances
- Buckman Co., Inc. — 2 clearances
- Jace Systems, Inc. — 2 clearances
- Bardon Ent., Inc. — 1 clearance
- Burke Neutech, Inc. — 1 clearance
