The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for Tens Device For Relief Of Chronic Pain, Modified.
| Device ID | K924876 |
| 510k Number | K924876 |
| Device Name: | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Contact | Sheryl A Harvey |
| Correspondent | Sheryl A Harvey GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1994-03-01 |