DYNATRON DX2 TRACTION UNIT
FDA 510(k) clearance K051680 · decided 2005-10-11
Clearance details
- K-number
- K051680
- Device name
- DYNATRON DX2 TRACTION UNIT
- Applicant
- Dynatronics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-23
- Decision date
- 2005-10-11
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.