FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
K Number: K897178
·
Decision Apr 18, 1990
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
24
Review Days
112
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
- DYNATRON 360 RANGE OF MOTION TESTING DEVICE
- K Number
- K897178
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dynatronics Corp.
- Date Received
- December 27, 1989
- Decision Date
- April 18, 1990
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQX), ordered by most recent decision date.
ORTELIUS 800
FDA 510(k)
FDA Class 1
·Orthopedic
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
FDA 510(k)
FDA Class 1
·Orthopedic
3D-SPINE
FDA 510(k)
FDA Class 1
·Orthopedic
SPINAL TOUCH
FDA 510(k)
FDA Class 1
·Orthopedic
INCLINOMETER
FDA 510(k)
FDA Class 1
·Orthopedic
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Dynatronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K132057 | DYNATRON PELTIER THERMOSTIM PROBE | Jan 24, 2014 | Substantially Equivalent |
| K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | Feb 9, 2012 | Substantially Equivalent |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | Jun 14, 2006 | Substantially Equivalent |
| K051680 | DYNATRON DX2 TRACTION UNIT | Oct 11, 2005 | Substantially Equivalent |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | Jul 25, 2005 | Substantially Equivalent |
| K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | Jan 7, 2005 | Unknown |
| K040729 | SOLARIS D890 THERAPY PROBE | Jun 2, 2004 | Substantially Equivalent |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Oct 22, 2003 | Substantially Equivalent |
| K010948 | DYNATRON STS RX | May 15, 2001 | Substantially Equivalent |
| K010565 | DYNATRON STS | May 15, 2001 | Substantially Equivalent |