The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gemore Muscle Conditioner;.
| Device ID | K102926 |
| 510k Number | K102926 |
| Device Name: | GEMORE MUSCLE CONDITIONER; |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Contact | Boden Lai |
| Correspondent | Boden Lai GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2011-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712832961775 | K102926 | 000 |
| 24712832961762 | K102926 | 000 |
| 24712832961755 | K102926 | 000 |
| 24712832961748 | K102926 | 000 |
| 24712832961731 | K102926 | 000 |