The following data is part of a premarket notification filed by Acumed Medical Supplies, Ltd. with the FDA for Tens Pro 900.
| Device ID | K023726 |
| 510k Number | K023726 |
| Device Name: | TENS PRO 900 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ACUMED MEDICAL SUPPLIES, LTD. 1151 HOPE ST. Stanford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen ACUMED MEDICAL SUPPLIES, LTD. 1151 HOPE ST. Stanford, CT 06907 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-06 |
| Decision Date | 2003-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628176737010 | K023726 | 000 |
| 10628176737000 | K023726 | 000 |