FDA product code NZD: Stretcher, Patient Restraint
NZD is the FDA product code for stretcher, patient restraint. It is a Class I device, regulated under 21 CFR 880.6900 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NZD. The average 510(k) review took 59 days (median 59). FDA has posted 2 recalls for NZD devices.
Definition
Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.
Classification
| Field | Value |
|---|---|
| Device name | Stretcher, Patient Restraint |
| Device class | Class I |
| Regulation | 21 CFR 880.6900 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every NZD clearance
Top NZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Emergency Products and Research | 1 | 2006-08-17 |
Most recent NZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061721 | Emergency Products and Research | PEDI-SPIDER STRAP | 2006-08-17 | 59 |
Recalls for NZD devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-10.
Frequently asked questions
What is FDA product code NZD?
NZD is the FDA product code for stretcher, patient restraint. It is a Class I device, regulated under 21 CFR 880.6900 and reviewed by the General Hospital panel.
What device class is NZD?
Class I, regulation 21 CFR 880.6900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NZD?
Across 1 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most NZD clearances?
Emergency Products and Research (1).
Have NZD devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2016-03-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NZD
- Run a recall and safety report across every NZD manufacturer
- Watch product code NZD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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