FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MYOTRAC+/S, MYODAC+/S
K Number: K913898
·
Decision Mar 26, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
22
Review Days
209
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Basic Information
- Device Name
- MYOTRAC+/S, MYODAC+/S
- K Number
- K913898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thought Technology , Ltd.
- Date Received
- August 30, 1991
- Decision Date
- March 26, 1992
- Product Code
- HCC
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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| K053266 | MYOTRAC INFINITI | Dec 29, 2005 | Substantially Equivalent |
| K925681 | MYOTRAC2D/CS | Sep 29, 1995 | Substantially Equivalent |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | May 11, 1995 | Substantially Equivalent |
| K935213 | INCONTROL | May 11, 1995 | Substantially Equivalent |
| K915858 | MYOTRAC2 | Sep 9, 1992 | Substantially Equivalent |
| K915859 | MYOTRAC/S, MYODAC/S | Sep 9, 1992 | Substantially Equivalent |
| K903497 | FLEXCOMP DSP & PROCOMP | Feb 12, 1991 | Substantially Equivalent |