The following data is part of a premarket notification filed by Pfizer Inc. with the FDA for Thermacare Quick Therapy Tens.
| Device ID | K181102 |
| 510k Number | K181102 |
| Device Name: | ThermaCare Quick Therapy TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Pfizer Inc. 235 East 42nd Street New York, NY 10017 |
| Contact | Nicola Romano |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-26 |
| Decision Date | 2018-09-15 |
| Summary: | summary |