Product Code: IOL
FDA class 1
21 CFR 890.5380
Treadmill, Powered
Physical Medicine
A Powered Treadmill is a motorized walking and running device used in Physical Medicine for cardiovascular rehabilitation, gait training, and exercise therapy, with a motor-driven belt providing a controlled walking surface at adjustable speeds and inclines. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOL, regulated under 21 CFR 890.5380, within the Physical Medicine medical specialty.
510(k)s
43
FEI Numbers
28
Registration Numbers
28
Unique Applicants
24
Years Active
19
Basic Information
- Product Code
- IOL
- Device Class
- FDA class 1
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 43 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950377 | PARKER MODEL PE | Sep 06, 1995 | Substantially Equivalent | PARKER TREADMILL CO., INC. |
| K950376 | PARKER MODEL PM | Sep 06, 1995 | Substantially Equivalent | PARKER TREADMILL CO., INC. |
| K925839 | TRACKMASTER | Jun 24, 1993 | Substantially Equivalent | JAS MANUFACTURING CO., INC. |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | May 26, 1993 | Substantially Equivalent | BIODAN MEDICAL SYSTEMS, LTD. |
| K904556 | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB | Dec 18, 1991 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K913518 | TA620 TREADMILL CONTROLLER | Oct 24, 1991 | Substantially Equivalent | SIEMENS BURDICK, INC. |
| K910867 | T600 TREADMILL | May 31, 1991 | Substantially Equivalent | SIEMENS BURDICK, INC. |
| K911751 | MEDTRACK TREADMILL | May 29, 1991 | Substantially Equivalent | QUINTON, INC. |
| K897179 | ORBITER(TM) TREADMILL | Feb 15, 1990 | Substantially Equivalent | LEE-MEREDITH INDUSTRIES, INC. |
| K895104 | AQUATREX UNDERWATER TREADMILL SYSTEM | Dec 04, 1989 | Substantially Equivalent | EDMONDS MEDICAL SYSTEMS |
| K893032 | PACER R 9 TREADMILL | Jul 27, 1989 | Substantially Equivalent | PACER INDUSTRIES, INC. |
| K890793 | STARTRAC | Mar 16, 1989 | Substantially Equivalent | UNISEN, INC. |
| K885062 | MODIFIED Q-SERIES OF TREADMILLS | Dec 27, 1988 | Substantially Equivalent | QUINTON, INC. |
| K864013 | MODEL Q55XT POWERED TREADMILL | Nov 14, 1986 | Substantially Equivalent | QUINTON, INC. |
| K863299 | MODIFIED Q50 MEDICAL TREADMILL | Sep 09, 1986 | Substantially Equivalent | QUINTON, INC. |
| K862741 | Q50 MEDICAL TREADMILL | Jul 29, 1986 | Substantially Equivalent | QUINTON, INC. |
| K861347 | R1596 POWERED EXERCISE EQUIPMENT | May 02, 1986 | Substantially Equivalent | TRI W-G, INC. |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | Dec 27, 1985 | Substantially Equivalent | BATTLE CREEK EQUIPMENT CO. |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | Dec 17, 1985 | Substantially Equivalent | BATTLE CREEK EQUIPMENT CO. |
| K854283 | CAMBRIDGE MODEL XT1000 | Nov 13, 1985 | Substantially Equivalent | CAMBRIDGE MEDICAL INSTRUMENTS, INC. |
| K851631 | TMX-C1/C2 TRADMILL CONTROLLER ACCESS. | Jul 15, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K851630 | TMX-80 TREADMILL | Jul 09, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K851629 | TMX-70 TREADMILL | Jul 09, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K850044 | TREADMILL E-17 | Apr 04, 1985 | Substantially Equivalent | DEL MAR AVIONICS |
| K843859 | LAUF-ERGOTEST JUNIOR | Nov 27, 1984 | Substantially Equivalent | ERICH JAEGER, INC. |
| K843853 | LAUF-ERGOTEST | Nov 27, 1984 | Substantially Equivalent | ERICH JAEGER, INC. |
| K840280 | ROAD RUNNER ELECTRIC TREADMILL | Feb 04, 1984 | Substantially Equivalent | BATTLE CREEK EQUIPMENT CO. |
| K833588 | VASCULAR LABORATORY TREADMILL VT1 | Nov 14, 1983 | Substantially Equivalent | MEDASONICS, INC. |
| K830146 | PROGRAM. TREADMILL CONTROLLER #645 | Feb 02, 1983 | Substantially Equivalent | QUINTON, INC. |
| K823003 | Q65 MEDICAL TREADMILL | Oct 27, 1982 | Substantially Equivalent | QUINTON, INC. |
| K820548 | POWERED TREADMILL | Mar 15, 1982 | Substantially Equivalent | OGDEN HEALTH PRODUCTS |
| K820478 | QUINTON Q55 MEDICAL TREADMILL | Mar 11, 1982 | Substantially Equivalent | QUINTON, INC. |
| K813486 | TELETRED GAIT ANALYSIS SYSTEM | Jan 29, 1982 | Substantially Equivalent | STRUCTURAL ANALYSIS SYSTEMS, INC. |
| K813485 | SAS EDUCATIONAL CHART | Jan 29, 1982 | Substantially Equivalent | STRUCTURAL ANALYSIS SYSTEMS, INC. |
| K802836 | SERIES 1800 EXERCISE TREADMILL | Dec 11, 1980 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K792661 | TREADMILL MODEL 3060 | Feb 19, 1980 | Substantially Equivalent | CAMBRIDGE INSTRUMENTS, INC. |
| K792590 | AP-1 AUTO PROGRAMMER | Jan 04, 1980 | Substantially Equivalent | BURDICK CORP. |
| K771697 | CARDIO-EXERCISE TREADMILL 550 | Sep 20, 1977 | Substantially Equivalent | QUINTON, INC. |
| K770240 | TREADMILL STRESS EXERCISE SYSTEM | Feb 14, 1977 | Substantially Equivalent | BURDICK CORP. |
| K761041 | POWERED TREADMILL (30/ST) | Dec 09, 1976 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K761040 | POWERED TREADMILL (20/ST) | Dec 09, 1976 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K760509 | TREADMILL, DIAGNOSTIC | Aug 30, 1976 | Substantially Equivalent | MEDCRAFT CORP. |
| K760275 | TREADMILL (TMS-300) | Aug 11, 1976 | Substantially Equivalent | BURDICK CORP. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.