FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RICH-MAR CARBON ELECTRODES
K Number: K950491
·
Decision Mar 29, 1995
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
43
Review Days
51
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Basic Information
- Device Name
- RICH-MAR CARBON ELECTRODES
- K Number
- K950491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rich-Mar Corp.
- Date Received
- February 6, 1995
- Decision Date
- March 29, 1995
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Rich-Mar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K040679 | RICH-MAR AUTOPRISM INFRARED LAMP | May 7, 2004 | Substantially Equivalent |
| K031018 | AUTOGEL PAD | Dec 8, 2003 | Substantially Equivalent |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Oct 22, 2003 | Substantially Equivalent |
| K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND | Sep 13, 2002 | Substantially Equivalent |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Jan 18, 2002 | Substantially Equivalent |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Jan 18, 2002 | Substantially Equivalent |
| K012848 | WINNER CM4 COMBINATION UNIT | Oct 25, 2001 | Substantially Equivalent |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | Aug 25, 2000 | Substantially Equivalent |
| K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES | Nov 19, 1998 | Substantially Equivalent |
| K952089 | RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE | Aug 11, 1995 | Substantially Equivalent for Some Indications |