The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gem-stone Abdominal Training System; Model Gem-tone 310pe/320pe/330pe/340pe/350pe..
| Device ID | K091833 |
| 510k Number | K091833 |
| Device Name: | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. |
| 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 | 2009-06-22 |
| Decision Date | 2009-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24712832961670 | K091833 | 000 |
| 24712832961359 | K091833 | 000 |
| 24712832961342 | K091833 | 000 |
| 24712832961335 | K091833 | 000 |
| 24712832961328 | K091833 | 000 |