FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NEURO-TRAIN II (2)
K Number: K970155
·
Decision Mar 17, 1997
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
6
Review Days
60
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEURO-TRAIN II (2)
- K Number
- K970155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterne Equipment Co., Ltd.
- Date Received
- January 16, 1997
- Decision Date
- March 17, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPF), ordered by most recent decision date.
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·Physical Medicine
High Tone Power therapy (HiToP) (Model: HiToP PNP)
FDA 510(k)
FDA Class 2
·Physical Medicine
StimelMD (SSMD) system
FDA 510(k)
FDA Class 2
·Physical Medicine
Compact II
FDA 510(k)
FDA Class 2
·Physical Medicine
EVE Synergy (EVE-20M)
FDA 510(k)
FDA Class 2
·Physical Medicine
TrainFES Advance
FDA 510(k)
FDA Class 2
·Physical Medicine
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 |
| K931279 | ACU-RAY | Nov 3, 1993 | Substantially Equivalent |
| K883896 | NEUROTRAIN | Jul 14, 1989 | Substantially Equivalent |