The following data is part of a premarket notification filed by Accelerated Care Plus with the FDA for Megapulse Iii Shortwave Diathermy.
Device ID | K153456 |
510k Number | K153456 |
Device Name: | Megapulse III Shortwave Diathermy |
Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
Applicant | Accelerated Care Plus 4999 Aircenter Circle, Suite 103 Reno, NV 89502 |
Contact | Patrick Parker |
Correspondent | Patrick Parker Accelerated Care Plus 4999 Aircenter Circle, Suite 103 Reno, NV 89502 |
Product Code | IMJ |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-01 |
Decision Date | 2016-06-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858703006085 | K153456 | 000 |