510(k) K790527

Device: BURNETT-KETCHUM DYNAMIC HAND EXERCISER
Applicant: MADDAK, INC.
510(k) number: K790527
Product code: JFA
Decision: Substantially Equivalent (SESE)
Decision date: 1979-03-22
Date received: 1979-03-15
Regulation: 890.5410
Classification name: Exerciser, Finger, Powered
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3007080381
3033847811
3011555947
2951574
3013517146
3043587013
3013440654
3023230906
3011150256
3010898730
3016071154
3012494290
3004438577
9617759
3021172399
3034731509
3013201082
3026818268

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JFA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K945803	THERMAFLEX, MODEL SD 55 C.P.M.H.	Burke Neutech, Inc.	1995-05-11
K931016	JACE MODEL H440 HAND CPM DEVICE	Jace Systems, Inc.	1994-06-22
K933418	HAND THERAPY ASSOST	Bardon Ent., Inc.	1994-04-28
K921351	JACE MODEL PM-410 HAND CPM DEVICE	Jace Systems, Inc.	1992-05-04
K900794	MOBILIMB H3 HAND CPM UNIT	Toronto 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. UNIT	Toronto Medical Corp.	1988-02-16
K860714	ACE AIM - CPM HAND UNIT	Buckman Co., Inc.	1986-03-27
K844033	MOBILIMB HAND UNIT	Danninger Medical Technology, Inc.	1984-11-27
K830974	SUTTER CPM 5000	Sutter Biomedical, Inc.	1983-04-12

Legacy Summary#

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