The following data is part of a premarket notification filed by R & D Medical Products, Inc. with the FDA for Comfort Stim.
| Device ID | K001117 |
| 510k Number | K001117 |
| Device Name: | COMFORT STIM |
| Classification | Electrode, Cutaneous |
| Applicant | R & D MEDICAL PRODUCTS, INC. 20492 CRESCENT BAY DR. #106 Lake Forest, CA 92630 |
| Contact | James Tran |
| Correspondent | James Tran R & D MEDICAL PRODUCTS, INC. 20492 CRESCENT BAY DR. #106 Lake Forest, CA 92630 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-06 |
| Decision Date | 2000-07-05 |