FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K Number: K000808
·
Decision Aug 25, 2000
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
43
Review Days
165
Basic Information
- Device Name
- RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
- K Number
- K000808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RICH-MAR CORP.
- Date Received
- March 13, 2000
- Decision Date
- August 25, 2000
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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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 |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Jan 18, 2002 | Substantially Equivalent |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Jan 18, 2002 | Substantially Equivalent |
| K012848 | WINNER CM4 COMBINATION UNIT | Oct 25, 2001 | 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 |
| K950564 | RICH-MAR US-II ULTRASOUND | May 15, 1995 | Substantially Equivalent |