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
K131899Substantially Equivalent

Sw-Therm

Shenzhen Dongdixin Technology Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K131899 is the FDA 510(k) clearance record for SW-THERM, a class II device, cleared for Shenzhen Dongdixin Technology Co., Ltd. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list 26 510(k) clearances for Shenzhen Dongdixin Technology Co., Ltd., from to . As of , FDA records show no recalls naming K131899.

Clearance record

Decision date
Received
(262 days to decision)
Product code
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Shenzhen Dongdixin Technology Co., Ltd. # 3 Bldg. Xilibaimang Xusheng Industrial Estate, Shenzhen, CN
510(k) summary
Statement
Third party review
No

Clearances, product code IMJ

Trailing 12 months
2 clearances under product code IMJ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IMJ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260