FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ANSiStim-PP
K Number: K170391
·
Decision Mar 9, 2017
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
22
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- ANSiStim-PP
- K Number
- K170391
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dyansys, Inc.
- Date Received
- February 8, 2017
- Decision Date
- March 9, 2017
- Product Code
- BWK
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| BWK | Stimulator, Electro-Acupuncture | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWK), ordered by most recent decision date.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
FDA 510(k)
FDA Unclassified
·Unknown
Needle Stimulator (Model: RJNS6-1)
FDA 510(k)
FDA Unclassified
·Unknown
Needle Stimulator
FDA 510(k)
FDA Unclassified
·Unknown
AXUS ES-5 Electro-Acupuncture Device
FDA 510(k)
FDA Unclassified
·Unknown
Stivax
FDA 510(k)
FDA Unclassified
·Unknown
ANSISTIM
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K213188 | Primary Relief | Jan 31, 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 |
| K141168 | ANSISTIM | May 15, 2015 | Substantially Equivalent |
| K091397 | ECSCOPE 200 | Jul 8, 2009 | Substantially Equivalent |