The following data is part of a premarket notification filed by Healthtronics, Inc. with the FDA for Ltfs230.
| Device ID | K021775 |
| 510k Number | K021775 |
| Device Name: | LTFS230 |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTHTRONICS, INC. 1841 WEST OAK PKWY. Marietta, GA 30062 |
| Contact | Peter Weiman |
| Correspondent | Peter Weiman HEALTHTRONICS, INC. 1841 WEST OAK PKWY. Marietta, GA 30062 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-12-23 |
| Summary: | summary |