The following data is part of a premarket notification filed by Encircle Medical Devices Ltd. with the FDA for Encircle Compression Therapy Stocking.
| Device ID | K122485 |
| 510k Number | K122485 |
| Device Name: | ENCIRCLE COMPRESSION THERAPY STOCKING |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | ENCIRCLE MEDICAL DEVICES LTD. 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron ENCIRCLE MEDICAL DEVICES LTD. 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2013-04-23 |