FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
MS-179 ELECTRONIC MUSCLE STIMULATOR
K Number: K862485
·
Decision Jul 16, 1986
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
8
Review Days
16
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Basic Information
- Device Name
- MS-179 ELECTRONIC MUSCLE STIMULATOR
- K Number
- K862485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Electro Med Supply, Inc.
- Date Received
- June 30, 1986
- Decision Date
- July 16, 1986
- 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 Electro Med Supply, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933368 | TENS-IT | Jun 7, 1994 | Substantially Equivalent |
| K872208 | MS-112, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K872206 | MD-104, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K872207 | MS-108, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K862487 | MS-139 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications |
| K862486 | MS-159 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications |
| K854801 | MS-189 MUSCLE STIMULATOR | Mar 27, 1986 | Substantially Equivalent |