510(k) K121743
- Device
- EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
- Applicant
- SUNMED LLC
- 510(k) number
- K121743
- Product code
- BXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-28
- Date received
- 2012-06-13
- Regulation
- 868.2775
- Classification name
- Stimulator, Nerve, Battery-powered
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WU TINGJIE
- Address
- C/O Easymed Instruments Co,5/ -6/F,Block A,Gupo Gongmao Bldg Fengxin Rd., Fengxiang Industrial District Daliang, Shunde, Foshan CN 528300 528300
FDA Registration Numbers#
- 2523676
- 2085602
- 3001650535
- 3009039068
- 3007699086
- 9610825
- 3015537323
- 9611612
- 9611481
- 1314417
- 3004049909
- 2183613
- 9614969
- 3013764800
- 3005581270
- 3004748541
- 3008773490
- 9611451
- 2022648
Source Documents#
Other 510(k) Records For Product Code BXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2022-10-16 |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | 2017-01-06 |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | 2016-05-13 |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | 2015-03-24 |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2014-11-06 |
| K111985 | MYOGUIDE SYSTEM MODEL 8008 | Intronix Technologies Corp. | 2011-12-30 |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2011-02-17 |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2010-12-16 |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2009-12-03 |
| K091155 | ASCEND | Neurometrix, Inc. | 2009-09-03 |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2007-11-15 |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | 2007-03-22 |
| K062478 | CLAVIS | Medtronic A/S | 2007-02-08 |
| K061983 | STIMUPLEX PEN | Stockert GmbH | 2006-11-21 |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | 2006-10-17 |
Legacy Summary#
summary
FDA Review#
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