Skip to product information
1 of 1

FDA 510(k) K093138, MT9000 Series Electro-Stimulator (MT9000-MT9004), by Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) K093138, MT9000 Series Electro-Stimulator (MT9000-MT9004), by Shenzhen Dongdixin Technology Co., Ltd.

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K093138
Device Name: MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003
Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.
Device Classification Name: stimulator, muscle, powered
Regulation Number: 890.5850
Classification Product Code: IPF
Date Received: 10/05/2009
Decision Date: 02/12/2010
Regulation Medical Specialty: Physical Medicine

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

View full details