The following data is part of a premarket notification filed by Bonutti Research, Inc. with the FDA for Jas Pulse(tm) Ultrasonic Therapy.
| Device ID | K161628 |
| 510k Number | K161628 |
| Device Name: | JAS Pulse(TM) Ultrasonic Therapy |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | Bonutti Research, Inc. P.O. Box 1367 Effingham, IL 62401 |
| Contact | Patrick G. Balsmann |
| Correspondent | Patrick G. Balsmann Bonutti Research, Inc. P.O. Box 1367 Effingham, IL 62401 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861681000327 | K161628 | 000 |
| 00861681000310 | K161628 | 000 |
| 00861681000303 | K161628 | 000 |