FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNATRON 800
K Number: K932937
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
24
Review Days
114
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Basic Information
- Device Name
- DYNATRON 800
- K Number
- K932937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dynatronics Corp.
- Date Received
- June 16, 1993
- Decision Date
- October 8, 1993
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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| 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 |