FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Primary Relief
K Number: K213188
·
Decision Jan 31, 2022
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
14
Review Days
124
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Basic Information
- Device Name
- Primary Relief
- K Number
- K213188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dyansys, Inc.
- Date Received
- September 29, 2021
- Decision Date
- January 31, 2022
- Product Code
- NHI
- 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 |
|---|---|---|---|
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHI), ordered by most recent decision date.
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Other Clearances by Dyansys, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221425 | Primary Relief | Sep 13, 2022 | Substantially Equivalent |
| K221231 | Drug Relief v1 | Jun 6, 2022 | Substantially Equivalent |
| K220397 | ANSiStim-PP | May 12, 2022 | Substantially Equivalent |
| K212859 | First Relief | Dec 20, 2021 | Substantially Equivalent |
| K211971 | Drug Relief v1 | Nov 5, 2021 | Substantially Equivalent |
| K202940 | First Relief v1 | Dec 29, 2020 | Substantially Equivalent |
| K173861 | Drug Relief | May 2, 2018 | Substantially Equivalent |
| K170391 | ANSiStim-PP | Mar 9, 2017 | Substantially Equivalent |
| K141168 | ANSISTIM | May 15, 2015 | Substantially Equivalent |
| K091397 | ECSCOPE 200 | Jul 8, 2009 | Substantially Equivalent |