Product Code: FPO
FDA class 2
21 CFR 880.6910
Stretcher, Wheeled
General Hospital
The Wheeled Stretcher is a mobile patient transport device equipped with wheels, used to move patients within a healthcare facility between departments, examination rooms, operating suites, or emergency areas. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPO, regulated under 21 CFR 880.6910 in the General Hospital specialty.
510(k)s
50
FEI Numbers
112
Registration Numbers
112
Unique Applicants
32
Years Active
35
Basic Information
- Product Code
- FPO
- Device Class
- FDA class 2
- Regulation Number
- 880.6910
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 50 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113598 | POWER-LOAD COT FASTENER SYSTEM | Dec 20, 2011 | Substantially Equivalent | STRYKER MEDICAL |
| K072598 | IRSG I-MOVER FOR BEDS | Apr 14, 2008 | Substantially Equivalent | INTERNATIONAL RETAIL SERVICES GROUP, LLC |
| K972528 | DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) | Jul 28, 1997 | Substantially Equivalent | DYNA CORP. |
| K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | Aug 07, 1996 | Substantially Equivalent | INTERNATIONAL BIOMEDICAL, INC. |
| K962181 | HARE MODEL 2000 EZ LOADER MODEL 95555 | Aug 01, 1996 | Substantially Equivalent | DYNA CORP. |
| K961437 | WHEELED STRETCHER | Jun 03, 1996 | Substantially Equivalent | HILL-ROM, INC. |
| K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | Nov 22, 1995 | Substantially Equivalent | HILL-ROM, INC. |
| K946101 | EMERGENCY/ACCIDENT TROLLEY 550 | Feb 07, 1995 | Substantially Equivalent | HOGAN & HARTSON |
| K945431 | MODEL 792 CONVERGE, MODEL 793 VISION 2000 | Jan 25, 1995 | Substantially Equivalent | HAUSTED, INC. |
| K943969 | MODEL 578 MOBILE SURGICAL STRETCHER | Jan 25, 1995 | Substantially Equivalent | HAUSTED, INC. |
| K942948 | STRYKER POWERED STRETCHER | Jan 24, 1995 | Substantially Equivalent | STRYKER CORP. |
| K943529 | PATIENT TROLLEY 540 | Oct 04, 1994 | Substantially Equivalent | MERIVAARA INSTRUMENTARIUM CORP. |
| K943528 | PATIENT TROLLEY 545 | Oct 04, 1994 | Substantially Equivalent | MERIVAARA INSTRUMENTARIUM CORP. |
| K943262 | FUTURA JUNIOR 300/310 | Sep 29, 1994 | Substantially Equivalent | MERIVAARA INSTRUMENTARIUM CORP. |
| K943864 | STRYKER 8000 SURGERY STRETCHER | Aug 25, 1994 | Substantially Equivalent | STRYKER MEDICAL |
| K935297 | STRYKER AMBULANCE COT MODEL 6060 | Feb 18, 1994 | Substantially Equivalent | STRYKER MEDICAL |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Feb 09, 1994 | Substantially Equivalent | MIDMARK CORP. |
| K933060 | S-610 & 2-628 WHEELED SHOWER STRETCHERS | Feb 04, 1994 | Substantially Equivalent | THE ANTHROS MEDICAL GROUP |
| K933071 | STS 701 TRANSPORT STRETCHER | Jan 26, 1994 | Substantially Equivalent | WY'EAST MEDICAL CORP. |
| K933366 | I.V. LINK | Jan 10, 1994 | Substantially Equivalent | DEVILLE LABORATORIES, INC. |
| K932260 | FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE | Sep 09, 1993 | Substantially Equivalent | FERNO |
| K922809 | GENERAL PROCEDURAL STRETCHERS (P880- P886) | Mar 31, 1993 | Substantially Equivalent | HILL-ROM, INC. |
| K922808 | HILL-ROM VIA STRETCHER (P1300 - P1303) | Mar 31, 1993 | Substantially Equivalent | HILL-ROM, INC. |
| K920704 | STRYKER I.V. CADDY ACCESSORY DEVICE | Mar 23, 1992 | Substantially Equivalent | STRYKER MEDICAL |
| K914543 | ST5500 UNIVERSAL CARE STRETCHER | Jan 08, 1992 | Substantially Equivalent | LIC CARE, INC. |
| K904011 | MODEL #527 OPHTHALMIC STRETCHER | Oct 03, 1990 | Substantially Equivalent | MIDMARK CORP. |
| K902503 | HARE FOLDING BACK EMERGENCY STRETCHER | Jun 26, 1990 | Substantially Equivalent | DYNA CORP. |
| K900872 | WHEELED STRETCHER | May 18, 1990 | Substantially Equivalent | HOSPITAL SUPPLY CO., INC. |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | Feb 22, 1990 | Substantially Equivalent | LUMEX, INC. |
| K884759 | SHOWER STRETCHER W/WHEELS | Jun 15, 1989 | Substantially Equivalent | LINIDO, INC. |
| K881845 | HARE ANY LEVEL COT | Jun 03, 1988 | Substantially Equivalent | DYNA INDUSTRIES, INC. |
| K874332 | MRI STRETCHER | Jan 05, 1988 | Substantially Equivalent | ATOMIC PRODUCTS CORP. |
| K873181 | STRETCHER, WHEELED, MECHANICAL | Oct 09, 1987 | Substantially Equivalent | CAMBRIDGE TECHNOLOGIES, INC. |
| K871556 | MERIVAARA EMERGENCY PATIENT TROLLEY #436 | Apr 30, 1987 | Substantially Equivalent | GLOBAL MEDICAL PRODS, INC. |
| K864269 | MODEL 35-B ALL LEVEL COT | Nov 13, 1986 | Substantially Equivalent | FERNO-WASHINGTON, INC. |
| K862959 | MERIVAARA PATIENT TROLLEY - MODEL #416 | Sep 25, 1986 | Substantially Equivalent | GLOBAL MEDICAL PRODS, INC. |
| K862441 | EZ LOAD MODEL 30, ALL LEVEL COT | Sep 12, 1986 | Substantially Equivalent | FERNO-WASHINGTON, INC. |
| K863083 | BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER | Sep 03, 1986 | Substantially Equivalent | BETA MEDICAL PRODUCTS CO. |
| K861410 | LIC MOBILE TRANSPORT STRETCHERS | Apr 22, 1986 | Substantially Equivalent | LADA INTL., INC. |
| K854304 | KEYMED OFFICE COUCH | Nov 12, 1985 | Substantially Equivalent | KEYMED, INC. |
| K853421 | THE KEYMED VARI-HEIGHT PATIENT COUCH | Sep 19, 1985 | Substantially Equivalent | KEYMED, INC. |
| K844578 | NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA | May 14, 1985 | Substantially Equivalent | ENGINEERING DYNAMICS CORP. |
| K843439 | CENTURIAN HYDRAULIC STRETCHER | Sep 13, 1984 | Substantially Equivalent | AMERICAN STERILIZER CO. |
| K840920 | KEYMED MOBILE ENDOSCOPY PATIENT COUCH | Mar 19, 1984 | Substantially Equivalent | KEYMED, INC. |
| K840125 | IURA UNIVERSAL WHEELCHAIR/STRETCHER- | Jan 27, 1984 | Substantially Equivalent | TRADE WEST, INC. |
| K840124 | IURA UNIVERSAL HOSPITAL STRETCHER-HS-13 | Jan 27, 1984 | Substantially Equivalent | TRADE WEST, INC. |
| K840122 | IURA AMBULANCE STRETCHER IAS-1 | Jan 27, 1984 | Substantially Equivalent | TRADE WEST, INC. |
| K801935 | PAD, HOSPITAL STRETCHER | Aug 27, 1980 | Substantially Equivalent | VOLUNTEER BLIND INDUSTRIES, INC. |
| K792570 | PATIENT TROLLEY B49 | Dec 31, 1979 | Substantially Equivalent | ETS RENE MARZET |
| K761147 | RELIANCE MOD-U-LINE M-700 | Jan 28, 1977 | Substantially Equivalent | F. & F. KOENIGKRAMER |
FEI Numbers
This FDA classification entry is associated with 112 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 112 registration numbers. Click on an entry to view related FDA registrations.