The following data is part of a premarket notification filed by Surgical Appliance Industries, Inc. with the FDA for Truform Ready-to-wear Compression Arm Sleece Truform Ready-to-wear Compression Gauntlet.
| Device ID | K121106 |
| 510k Number | K121106 |
| Device Name: | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | SURGICAL APPLIANCE INDUSTRIES, INC. 3960 ROSSLYN DR. Cincinnati, OH 45209 |
| Contact | Gary Parsons |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-04-27 |
| Summary: | summary |