FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIMTECH NEUROMUSCULAR STIMULATOR, C 600
K Number: K791048
·
Decision Jul 3, 1979
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- STIMTECH NEUROMUSCULAR STIMULATOR, C 600
- K Number
- K791048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Stimulation Technology, Inc.
- Date Received
- June 6, 1979
- Decision Date
- July 3, 1979
- 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 Stimulation Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790345 | STIMTECH TENS ELECTRODE | Mar 21, 1979 | Substantially Equivalent |
| K781565 | ELECTRICAL NERVE STIMULATOR MODEL 6035 | Oct 11, 1978 | Substantially Equivalent |
| K772224 | NERVE STIMULATOR, ELEC. TRANSCUTANEOUS | Dec 15, 1977 | Substantially Equivalent |
| K770448 | INS - T.E.N.S. | Mar 15, 1977 | Substantially Equivalent |
| K770447 | EPC INSTICKS | Mar 15, 1977 | Substantially Equivalent |