The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd. with the FDA for Jiajian Pointoselect Digital.
| Device ID | K123958 |
| 510k Number | K123958 |
| Device Name: | JIAJIAN POINTOSELECT DIGITAL |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. ROOM 1706, NO.128 SONGLE RD SONGJIANG AREA Shanghai, CN 201600 |
| Contact | Doris Dong |
| Correspondent | Doris Dong WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. ROOM 1706, NO.128 SONGLE RD SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-21 |
| Decision Date | 2013-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810011251502 | K123958 | 000 |
| 18150050215000 | K123958 | 000 |
| 16972011713501 | K123958 | 000 |
| 00815005021505 | K123958 | 000 |