FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR
K Number: K861739
·
Decision Jun 9, 1986
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
2
Review Days
34
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Basic Information
- Device Name
- TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR
- K Number
- K861739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- J.A. Preston Corp.
- Date Received
- May 6, 1986
- Decision Date
- June 9, 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 J.A. Preston Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K830747 | PC 2909A-HEALTH PULSE CONTROL STIMULATOR | May 30, 1983 | Substantially Equivalent |