The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Pam Plus.
| Device ID | K913998 |
| 510k Number | K913998 |
| Device Name: | PAM PLUS |
| Classification | Vibrator, Therapeutic |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Contact | William H Quirk |
| Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1992-01-08 |