The following data is part of a premarket notification filed by Dalian Labtek Science & Development Co., Ltd. with the FDA for Intermittent Pneumatic Compression Device.
| Device ID | K123830 |
| 510k Number | K123830 |
| Device Name: | INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. RM 1706 YUESHA, NO. 128 SONGLE RD, SONGJIANG AREA Shanghai, CN 201600 |
| Contact | Doris Dong |
| Correspondent | Doris Dong DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. RM 1706 YUESHA, NO. 128 SONGLE RD, SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-08-16 |
| Summary: | summary |