The following data is part of a premarket notification filed by Intelsource Group, Inc. with the FDA for Wellnesspro 2010.
| Device ID | K062616 |
| 510k Number | K062616 |
| Device Name: | WELLNESSPRO 2010 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | INTELSOURCE GROUP, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith INTELSOURCE GROUP, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2007-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861284002605 | K062616 | 000 |
| B243SSWP2010PLUS0 | K062616 | 000 |