The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Bioscope Sd Tens, Arista Sd Plus, Ap-102080t.
| Device ID | K970429 |
| 510k Number | K970429 |
| Device Name: | BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Contact | Daniel Lee |
| Correspondent | Daniel Lee APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-04-29 |