The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Compression Devices, Limb.
| Device ID | K781964 |
| 510k Number | K781964 |
| Device Name: | COMPRESSION DEVICES, LIMB |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | ALBA-WALDENSIAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-20 |
| Decision Date | 1978-12-12 |