The following data is part of a premarket notification filed by Mantra Intl. (hk) Ltd. with the FDA for Mantra Combo, Model Mecs 320.
| Device ID | K091236 |
| 510k Number | K091236 |
| Device Name: | MANTRA COMBO, MODEL MECS 320 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MANTRA INTL. (HK) LTD. 4663 KATE LANE Oxford, OH 45056 |
| Contact | Brent Reider |
| Correspondent | Brent Reider MANTRA INTL. (HK) LTD. 4663 KATE LANE Oxford, OH 45056 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-07-30 |
| Summary: | summary |