The following data is part of a premarket notification filed by Hougen Mfg., Inc. with the FDA for X-air-ciser.
| Device ID | K974849 |
| 510k Number | K974849 |
| Device Name: | X-AIR-CISER |
| Classification | Percussor, Powered-electric |
| Applicant | HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
| Contact | Jeffery R Miller |
| Correspondent | Jeffery R Miller HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10383480000065 | K974849 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() X-AIR-CISER 75787112 not registered Dead/Abandoned |
Hougen Manufacturing, Inc. 1999-08-27 |
![]() X-AIR-CISER 75237195 not registered Dead/Abandoned |
Hougen Manufacturing, Inc. 1997-02-06 |