FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K Number: K932149
·
Decision May 11, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
22
Review Days
737
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Basic Information
- Device Name
- THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
- K Number
- K932149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thought Technology , Ltd.
- Date Received
- May 4, 1993
- Decision Date
- May 11, 1995
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Thought Technology , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213197 | MyOnyx System | Jun 17, 2022 | Substantially Equivalent |
| K201014 | MyOnyx System | Jan 13, 2021 | Substantially Equivalent |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | Mar 15, 2006 | Substantially Equivalent |
| K053266 | MYOTRAC INFINITI | Dec 29, 2005 | Substantially Equivalent |
| K925681 | MYOTRAC2D/CS | Sep 29, 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 |
| K913898 | MYOTRAC+/S, MYODAC+/S | Mar 26, 1992 | Substantially Equivalent |
| K903497 | FLEXCOMP DSP & PROCOMP | Feb 12, 1991 | Substantially Equivalent |