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510(k) K061721

PEDI-SPIDER STRAP by Emergency Products and Research — Product Code NZD

K061721 is an FDA 510(k) premarket notification submitted by Emergency Products and Research for the device "PEDI-SPIDER STRAP". The FDA issued a decision of Substantially Equivalent on August 17, 2006. The device falls under product code NZD (Stretcher, Patient Restraint), a Class I device regulated under 21 CFR 880.6900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2006
Date Received
June 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Patient Restraint
Device Class
Class I
Regulation Number
880.6900
Review Panel
HO
Submission Type

Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.

FDA data resources