The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Digital Tens Ts1211, Ts1212.
| Device ID | K021755 |
| 510k Number | K021755 |
| Device Name: | APEX MEDICAL DIGITAL TENS TS1211, TS1212 |
| 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 | Alan Chang |
| Correspondent | Alan Chang 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-06-12 |