NZD · Stretcher, Patient Restraint
General Hospital · 21 CFR 880.6900 · Class 1
Overview
| Product Code | NZD |
|---|---|
| Device Name | Stretcher, Patient Restraint |
| Regulation | 21 CFR 880.6900 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061721 | PEDI-SPIDER STRAP | Emergency Products and Research | Aug 17, 2006 | SESE |
Top Applicants
- Emergency Products and Research — 1 clearance
