The following data is part of a premarket notification filed by Jkh Health Co., Ltd. with the FDA for Overlapped Compression Therapy.
| Device ID | K202839 |
| 510k Number | K202839 |
| Device Name: | Overlapped Compression Therapy |
| Classification | Sleeve, Limb, Compressible |
| Applicant | JKH HEALTH CO., LTD. 4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area, Shajing, Baoan Shenzhen, CN 518104 |
| Contact | Pu Jiang |
| Correspondent | Pu Jiang JKH HEALTH CO., LTD. 4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area, Shajing, Baoan Shenzhen, CN 518104 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446724377 | K202839 | 000 |