Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Massager, Therapeutic, Electric
510(k) Number K221865
Device Name BTL-094
Applicant
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number890.5660
Classification Product Code
ISA  
Date Received06/27/2022
Decision Date 04/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-