Product code JFA— Physical Medicine

FDA has cleared 12 devices under product code JFA between 1979 and 1995, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19951 clearance
• 19942 clearances
• 19921 clearance
• 19902 clearances
• 19882 clearances
• 19861 clearance
• 19841 clearance
• 19831 clearance
• 19791 clearance

• Toronto Medical Corp.3 clearances
• Jace Systems, Inc.2 clearances
• Buckman Co., Inc.2 clearances
• Sutter Biomedical, Inc.1 clearance
• Maddak, Inc.1 clearance
• Danninger Medical Technology, Inc.1 clearance
• Burke Neutech, Inc.1 clearance
• Bardon Ent., Inc.1 clearance

• K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H.Burke Neutech, Inc.·1995-05-11
• K931016 — JACE MODEL H440 HAND CPM DEVICEJace Systems, Inc.·1994-06-22
• K933418 — HAND THERAPY ASSOSTBardon Ent., Inc.·1994-04-28
• K921351 — JACE MODEL PM-410 HAND CPM DEVICEJace Systems, Inc.·1992-05-04
• K900794 — MOBILIMB H3 HAND CPM UNITToronto Medical Corp.·1990-03-02
• K900581 — DANNIFLEX CPM 880(TM)Buckman Co., Inc.·1990-02-20
• K880686 — TORONTO/MOBILIMB HAND C.P.M.Toronto Medical Corp.·1988-02-26
• K880336 — MOBILIMB HAND C.P.M. UNITToronto Medical Corp.·1988-02-16
• K860714 — ACE AIM - CPM HAND UNITBuckman Co., Inc.·1986-03-27
• K844033 — MOBILIMB HAND UNITDanninger Medical Technology, Inc.·1984-11-27
• K830974 — SUTTER CPM 5000Sutter Biomedical, Inc.·1983-04-12
• K790527 — BURNETT-KETCHUM DYNAMIC HAND EXERCISERMaddak, Inc.·1979-03-22