The following data is part of a premarket notification filed by American Medical Corp. with the FDA for American Medical Mfg. Lumbar Cpm.
| Device ID | K922493 |
| 510k Number | K922493 |
| Device Name: | AMERICAN MEDICAL MFG. LUMBAR CPM |
| Classification | Exerciser, Powered |
| Applicant | AMERICAN MEDICAL CORP. 90 SARATOGA DR. Lawrenceville, GA 30244 |
| Contact | Michelle J Alsup |
| Correspondent | Michelle J Alsup AMERICAN MEDICAL CORP. 90 SARATOGA DR. Lawrenceville, GA 30244 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-07-27 |