Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K240234

BTL-899MS

510(k) number
K240234
Device name
BTL-899MS
Applicant
BTL Industries, Inc. MA · US
Product code
IPF — Stimulator, Muscle, Powered
Decision date
2024-08-17
Date received
2024-01-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K240234.pdf

Official FDA record: K240234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.