The following data is part of a premarket notification filed by B & J Manufacturing Ltd. with the FDA for B&j Dvt Calf/thigh Garments, Models 801/830 Series.
| Device ID | K201532 |
| 510k Number | K201532 |
| Device Name: | B&J DVT Calf/Thigh Garments, Models 801/830 Series |
| Classification | Sleeve, Limb, Compressible |
| Applicant | B & J Manufacturing Ltd. Room 701 & 101, Building 24, Block B, Yuanshan Industrial Zone, Gongming Shenzhen, CN 518106 |
| Contact | Billy Yu |
| Correspondent | Fu Ailing Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Block A, Time Square, Xili Town Shenzhen, CN 518055 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975298105000 | K201532 | 000 |
| 16975298105014 | K201532 | 000 |
| 16975298105120 | K201532 | 000 |
| 16975298105113 | K201532 | 000 |
| 16975298105106 | K201532 | 000 |
| 16975298105090 | K201532 | 000 |
| 16975298105083 | K201532 | 000 |
| 16975298105076 | K201532 | 000 |
| 16975298105069 | K201532 | 000 |