510(k) K061721
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.