510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K131660Substantially Equivalent

Smart (Smart-D, Smart-Dx)

Bts S.p.A., Padova, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131660 is the FDA 510(k) clearance record for SMART (SMART-D, SMART-DX), a class II device, cleared for Bts S.P.A. on under FDA product code LXJ (Interactive Rehabilitation Exercise Devices). FDA records list 2 510(k) clearances for Bts S.P.A., from to . As of , FDA records show no recalls naming K131660.

Clearance record

Decision date
Received
(315 days to decision)
Product code
LXJ Interactive Rehabilitation Exercise Devices
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Bts S.P.A. Via Croce Rossa, 11, Padova, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXJ

Trailing 12 months

FDA records hold no clearances under product code LXJ in the trailing twelve months.

FDA records show no clearances under product code LXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260