Stretcher, Patient Restraint
The Stretcher, Patient Restraint (product code NZD) consists of soft restraints designed to be attached to a backboard or stretcher to immobilize patients in emergency situations. It is classified as FDA Class 1, GMP-exempt, and regulated under 21 CFR 880.6900 within the General Hospital specialty. The device is subject to general controls only and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZD
- Device Class
- FDA class 1
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061721 | PEDI-SPIDER STRAP | Aug 17, 2006 | Substantially Equivalent | Emergency Products and Research |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.