The following data is part of a premarket notification filed by Apos Medical Assets Ltd. with the FDA for Apostherapy System.
| Device ID | K182090 |
| 510k Number | K182090 |
| Device Name: | AposTherapy System |
| Classification | Shoe With Adjustable Sole Units |
| Applicant | APOS Medical Assets Ltd. 7 Hapelech Street Tel Aviv, IL 6816727 |
| Contact | Cliff Bleustein |
| Correspondent | Janice Hogan Hogan Lovells U.S. LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | QDT |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290019388224 | K182090 | 000 |
| 17290019388422 | K182090 | 000 |
| 17290019388415 | K182090 | 000 |
| 17290019388408 | K182090 | 000 |
| 17290019388392 | K182090 | 000 |
| 17290019388385 | K182090 | 000 |
| 17290019388378 | K182090 | 000 |
| 17290019388361 | K182090 | 000 |
| 17290019388354 | K182090 | 000 |
| 17290019388347 | K182090 | 000 |
| 17290019388330 | K182090 | 000 |
| 17290019388323 | K182090 | 000 |
| 17290019388316 | K182090 | 000 |
| 17290019388309 | K182090 | 000 |
| 17290019388231 | K182090 | 000 |
| 17290019388248 | K182090 | 000 |
| 17290019388217 | K182090 | 000 |
| 17290019388200 | K182090 | 000 |
| 17290019388194 | K182090 | 000 |
| 17290019388187 | K182090 | 000 |
| 07290019388173 | K182090 | 000 |
| 17290019388163 | K182090 | 000 |
| 17290019388156 | K182090 | 000 |
| 07290019388142 | K182090 | 000 |
| 07290019388135 | K182090 | 000 |
| 17290019388286 | K182090 | 000 |
| 17290019388279 | K182090 | 000 |
| 17290019388262 | K182090 | 000 |
| 17290019388255 | K182090 | 000 |
| 17290019388293 | K182090 | 000 |