The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Transcoutaneous Electro-neuro Stimulator.
Device ID | K884972 |
510k Number | K884972 |
Device Name: | TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Contact | Morad Davoudzadeh |
Correspondent | Morad Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-30 |
Decision Date | 1989-07-27 |