FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NEUROTRAIN
K Number: K883896
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
6
Review Days
303
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Basic Information
- Device Name
- NEUROTRAIN
- K Number
- K883896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Sterne Equipment Co., Ltd.
- Date Received
- September 14, 1988
- Decision Date
- July 14, 1989
- Product Code
- LIH
- 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | FDA class 2 | Neurology |
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Other Clearances by Sterne Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K003433 | NEURO-TRAIN III (3) | Jun 15, 2001 | Substantially Equivalent |
| K980158 | MYO-TRAIN V (5) | Jul 28, 1998 | Substantially Equivalent |
| K972204 | ACU-RAY HF SERIES PORTABLE X-RAY UNIT | Oct 8, 1997 | Substantially Equivalent |
| K970155 | NEURO-TRAIN II (2) | Mar 17, 1997 | Substantially Equivalent |
| K931279 | ACU-RAY | Nov 3, 1993 | Substantially Equivalent |