The following data is part of a premarket notification filed by Koalaty Products, Inc. with the FDA for Tens Stimulator, Models 2800 And 3000.
| Device ID | K102014 |
| 510k Number | K102014 |
| Device Name: | TENS STIMULATOR, MODELS 2800 AND 3000 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | KOALATY PRODUCTS, INC. # 3 BLDG, XILIYANGGUANG IND ES XILIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Kang Jiang Ping |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80813520010772 | K102014 | 000 |
| 80092237615955 | K102014 | 000 |
| 80092237616402 | K102014 | 000 |
| 80092237618703 | K102014 | 000 |
| 80092237618734 | K102014 | 000 |
| 80092237618765 | K102014 | 000 |
| 00858688006261 | K102014 | 000 |
| 00858688006285 | K102014 | 000 |
| 00858688006704 | K102014 | 000 |
| 80092237612879 | K102014 | 000 |