510(k) K093322
- Device
- MULTI-PURPOSE HEALTH DEVICE
- Applicant
- Upc Medical Supplies, Inc. Dba United Pacific Co.
- 510(k) number
- K093322
- Product code
- BWK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-05
- Date received
- 2009-10-23
- Classification name
- Stimulator, Electro-Acupuncture
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL HUE
- Address
- 317 S. San Marino Ave. San Gabriel CA US 91776 91776
FDA Registration Numbers#
- 8043792
- 3010363503
- 3010350335
- 3003836669
- 9614750
- 3007710601
- 3012184208
- 3001110146
- 2939821
- 3003755374
- 3023237645
- 9613446
- 3011743372
- 3009445917
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BWK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 |
| K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-03-18 |
| K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 |
| K200636 | AXUS ES-5 Electro-Acupuncture Device | Lhasa Oms, Inc. | 2021-02-03 |
| K170391 | ANSiStim-PP | Dyansys, Inc. | 2017-03-09 |
| K152571 | Stivax | Biegler GmbH | 2016-05-26 |
| K141168 | ANSISTIM | Dyansys, Inc. | 2015-05-15 |
| K133980 | PANTHEON ELECTROSTIMULATOR | Pantheon Research | 2014-11-07 |
| K140530 | Electro Auricular Device | Navigant Consulting, Inc. | 2014-10-02 |
| K140788 | P-STIM | Biegler GmbH | 2014-06-27 |
| K130768 | JIAJIAN CMN STIMULATOR | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 |
| K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 |
| K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Inno-Health Technology, Inc. | 2010-04-02 |
| K091875 | E-PULSE | Medevice Corporation | 2009-12-07 |
| K081943 | MODEL ES-130 | Ito Co., Ltd. | 2008-11-24 |