The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Low Back Pain Relief System /models Gm310pp,gm320pp,gm321pp, And Gm330pp.
| Device ID | K060222 |
| 510k Number | K060222 |
| Device Name: | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Contact | Boden S.p. Lai |
| Correspondent | Boden S.p. Lai GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-30 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24712832961311 | K060222 | 000 |
| 24712832961304 | K060222 | 000 |
| 24712832961298 | K060222 | 000 |
| 24712832960628 | K060222 | 000 |