The following data is part of a premarket notification filed by Fuji Dynamics Ltd with the FDA for Ll Tens 160a, Ll Tens 160b.
| Device ID | K152374 |
| 510k Number | K152374 |
| Device Name: | LL TENS 160A, LL TENS 160B |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Fuji Dynamics Ltd 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong, CN |
| Contact | Man Man Chung |
| Correspondent | Man Man Chung Fuji Dynamics Ltd 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong, CN |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-21 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853455007083 | K152374 | 000 |
| 00853455007076 | K152374 | 000 |