The following data is part of a premarket notification filed by Eischoco, Inc. with the FDA for Intermittent Compression Boot For Otc.
| Device ID | K991921 |
| 510k Number | K991921 |
| Device Name: | INTERMITTENT COMPRESSION BOOT FOR OTC |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | EISCHOCO, INC. 1232 S.E. 282ND AVE. Gresham, OR 97080 |
| Contact | Clem Eischen |
| Correspondent | Clem Eischen EISCHOCO, INC. 1232 S.E. 282ND AVE. Gresham, OR 97080 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 1999-08-13 |
| Summary: | summary |