The following data is part of a premarket notification filed by Champion Mfg. Corp. with the FDA for Champion Physioacousticc Recliner-transporter Chair.
| Device ID | K951414 |
| 510k Number | K951414 |
| Device Name: | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR |
| Classification | Vibrator, Therapeutic |
| Applicant | CHAMPION MFG. CORP. 5660 STATE RD. 5 N. P. O. BOX 277 SHIPSHEWANA, IN 46565 |
| Contact | W J CHAMBERLAIN |
| Correspondent | W J CHAMBERLAIN CHAMPION MFG. CORP. 5660 STATE RD. 5 N. P. O. BOX 277 SHIPSHEWANA, IN 46565 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-08-11 |