ANSiStim-PP
FDA 510(k) clearance K170391 · decided 2017-03-09
Clearance details
- K-number
- K170391
- Device name
- ANSiStim-PP
- Applicant
- Dyansys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-08
- Decision date
- 2017-03-09
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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| Stivax (K152571) | Biegler GmbH | 2016-05-26 |
| ANSISTIM (K141168) | Dyansys, Inc. | 2015-05-15 |
| PANTHEON ELECTROSTIMULATOR (K133980) | Pantheon Research | 2014-11-07 |
| Electro Auricular Device (K140530) | Navigant Consulting, Inc. | 2014-10-02 |
| P-STIM (K140788) | Biegler GmbH | 2014-06-27 |
| JIAJIAN CMN STIMULATOR (K130768) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 |
| JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (K122812) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 |
| MULTI-PURPOSE HEALTH DEVICE (K093322) | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
Recalls involving this device
No recalls on record reference this clearance.