The following data is part of a premarket notification filed by Walling Medical Equipment Co. with the FDA for Charger (ed).
| Device ID | K980567 |
| 510k Number | K980567 |
| Device Name: | CHARGER (ED) |
| Classification | Device, External Penile Rigidity |
| Applicant | WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070 |
| Contact | Allan Walling |
| Correspondent | Allan Walling WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-13 |
| Decision Date | 1998-05-06 |
| Summary: | summary |