FPP · Stretcher, Hand-Carried
General Hospital · 21 CFR 880.6900 · Class 1
Overview
| Product Code | FPP |
|---|---|
| Device Name | Stretcher, Hand-Carried |
| 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 (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030283 | BABY POD | Prism Enterprises, Inc. | Apr 22, 2003 | SESE |
| K942356 | MED-EVAC-4 MEDICAL EVACUATION STRETCHER | Montery Bay Corp. | Jul 19, 1994 | SESE |
| K940130 | STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER | Stryker Corp. | Mar 10, 1994 | SESE |
| K940245 | EVACU-SLED | Evacu Technologies, Inc. | Feb 28, 1994 | SESE |
| K924275 | RESTRAINING STRETCHER | Dms | Jul 27, 1993 | SESE |
| K922816 | U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER | Up Custom Design, Inc. | Jul 13, 1993 | SESE |
| K924669 | FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W | Ferno | Apr 29, 1993 | SESE |
| K920805 | LIFE LITE EMERGENCY STRETCHER | Design Principles, Inc. | May 22, 1992 | SESE |
| K915874 | BASKET LITTER CARRIER | Bradco Med , Ltd. | May 13, 1992 | SESE |
| K914140 | GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED | Bissell Medical Products, Inc. | Mar 31, 1992 | SESE |
| K913520 | EVACU SLED | Nexus Health Care Products , Ltd. | Dec 4, 1991 | SESE |
| K911765 | HAND CARRIED STRETCHER | L.E. Phillips Career Development Center, Inc. | Jun 14, 1991 | SESE |
| K904237 | RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM | Innovative Medical Technologies, Inc. | May 9, 1991 | SESE |
| K910709 | WEEVAC TC HAND CARRIED RESCUE STRETCHER | W. Murphy Ent., Inc. | Apr 1, 1991 | SESE |
| K905381 | MANHANDLER | Lifeport, Inc. | Mar 13, 1991 | SESE |
| K904511 | HAND-CARRIED STRETCHERS/BREAK AWAY FLAT | Minto Research & Development, Inc. | Oct 12, 1990 | SESE |
| K904494 | HAND-CARRIED STRETCHERS | Minto Research & Development, Inc. | Oct 12, 1990 | SESE |
| K904261 | LITTER, NONRIDGID, POLELESS, NYLON STRETCHER | Dow Cover Co., Inc. | Oct 12, 1990 | SESE |
| K902474 | WEEVAC 1 PORTABLE RESCUE STRETCHER | W. Murphy Ent., Inc. | Jul 24, 1990 | SESE |
| K901760 | LITTER, FOLDING RIGID POLE, DECONTAMINABLE | Dept. of the Army | Jul 10, 1990 | SESE |
Top Applicants
- Araluen, Inc. — 3 clearances
- W. Murphy Ent., Inc. — 3 clearances
- Dyna Corp. — 2 clearances
- Minto Research & Development, Inc. — 2 clearances
- Skedco, Inc. — 2 clearances
