510(k) K900588
- Device
- ACU-BAND ACCUPRESSURE WRIST BAND
- Applicant
- EURO-AM PHARMA, INC.
- 510(k) number
- K900588
- Product code
- BWK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-22
- Date received
- 1990-02-07
- Regulation
- 510(k) Premarket Notification
- Classification name
- Stimulator, Electro-acupuncture
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GYAN, PHD
- Address
- 64 Montrose Ave. Fanwood NJ US 07023 07023
FDA Registration Numbers#
- 8044105
- 3009155880
- 2000004234
- 3003062321
- 3005630901
- 3009068676
- 2183416
- 3007740394
- 3016195105
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 |
| K093322 | MULTI-PURPOSE HEALTH DEVICE | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
| K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Inno-Health Technology, Inc. | 2010-04-02 |
| K091875 | E-PULSE | Medevice Corporation | 2009-12-07 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases