Exerciser, Finger, Powered
A Powered Finger Exerciser is a physical medicine device that uses motorized or powered mechanisms to repetitively move and rehabilitate the fingers, assisting patients recovering from hand injuries, surgeries, or neurological conditions affecting finger mobility. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JFA, regulated under 21 CFR 890.5410, within the Physical Medicine medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JFA
- Device Class
- FDA class 1
- Regulation Number
- 890.5410
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | May 11, 1995 | Substantially Equivalent | Burke Neutech, Inc. |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | Jun 22, 1994 | Substantially Equivalent | Jace Systems, Inc. |
| K933418 | HAND THERAPY ASSOST | Apr 28, 1994 | Substantially Equivalent | Bardon Ent., Inc. |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | May 04, 1992 | Substantially Equivalent | Jace Systems, Inc. |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Mar 02, 1990 | Substantially Equivalent | Toronto Medical Corp. |
| K900581 | DANNIFLEX CPM 880(TM) | Feb 20, 1990 | Substantially Equivalent | Buckman Co., Inc. |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Feb 26, 1988 | Substantially Equivalent | Toronto Medical Corp. |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Feb 16, 1988 | Substantially Equivalent | Toronto Medical Corp. |
| K860714 | ACE AIM - CPM HAND UNIT | Mar 27, 1986 | Substantially Equivalent | Buckman Co., Inc. |
| K844033 | MOBILIMB HAND UNIT | Nov 27, 1984 | Substantially Equivalent | Danninger Medical Technology, Inc. |
| K830974 | SUTTER CPM 5000 | Apr 12, 1983 | Substantially Equivalent | Sutter Biomedical, Inc. |
| K790527 | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Mar 22, 1979 | Substantially Equivalent | Maddak, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.