The following data is part of a premarket notification filed by Electro Therapeutic Devices, Inc. with the FDA for Addiquip Disposable Acupuncture Needles.
| Device ID | K981272 |
| 510k Number | K981272 |
| Device Name: | ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
| Contact | K C Choong |
| Correspondent | K C Choong ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-08-24 |
| Summary: | summary |