FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Scrambler Therapy Technology (Model ST-5A)
K Number: K201458
·
Decision Dec 23, 2020
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
2
Review Days
205
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Basic Information
- Device Name
- Scrambler Therapy Technology (Model ST-5A)
- K Number
- K201458
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Delta International Services & Logistics S.R.L
- Date Received
- June 1, 2020
- Decision Date
- December 23, 2020
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Delta International Services & Logistics S.R.L
| K Number | Device Name | ||
|---|---|---|---|
| K142666 | Scrambler Therapy MC-5 A Device | May 22, 2015 | Substantially Equivalent |