FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROGRAM. TREADMILL CONTROLLER #645
K Number: K830146
·
Decision Feb 2, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
164
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROGRAM. TREADMILL CONTROLLER #645
- K Number
- K830146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- January 17, 1983
- Decision Date
- February 2, 1983
- Product Code
- IOL
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOL | Treadmill, Powered | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOL), ordered by most recent decision date.
PARKER MODEL PM
FDA 510(k)
FDA Class 1
·Physical Medicine
PARKER MODEL PE
FDA 510(k)
FDA Class 1
·Physical Medicine
TRACKMASTER
FDA 510(k)
FDA Class 1
·Physical Medicine
RTM REHABILITATION TREADMILL, MODEL #945-200
FDA 510(k)
FDA Class 1
·Physical Medicine
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
FDA 510(k)
FDA Class 1
·Physical Medicine
TA620 TREADMILL CONTROLLER
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Quinton, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | Sep 5, 2003 | Substantially Equivalent |
| K021906 | QUINTON Q-CATH, MODEL 000460 | Sep 4, 2002 | Substantially Equivalent |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Jan 25, 2001 | Substantially Equivalent |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | Aug 9, 2000 | Substantially Equivalent |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Mar 6, 2000 | Substantially Equivalent |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Apr 29, 1999 | Substantially Equivalent |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | Substantially Equivalent |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | Aug 13, 1997 | Substantially Equivalent |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | Sep 13, 1996 | Substantially Equivalent |