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510(k) K963479

Device
WHEELCHAIR BELT
Applicant
DEROYAL INDUSTRIES, INC.
510(k) number
K963479
Product code
KID  
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-24
Date received
1996-09-03
Regulation
890.3910
Classification name
Restraint, Wheelchair, Non-protective
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAMILLE MATLOCK
Address
200 Debusk Ln. Powell TN US 37849 37849

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963475PONCHO VEST RESTRAINTDeroyal Industries, Inc.1997-01-22
K963480MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDERDeroyal Industries, Inc.1997-01-22
K963459SUPPORT VESTSkil-Care Corp.1996-10-15
K963461SAFETY PONCHO/SHOULDER STRAP PONCHOSkil-Care Corp.1996-10-11
K963455SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROLSkil-Care Corp.1996-10-08
K802603ECONO-FLOAT WHEELCHAIR FLOTATION CUSHIONJefferson Industries, Inc.1980-11-12

Legacy Summary#

summary

FDA Review#

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