510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K071093Substantially Equivalent

San Shih Powered Muscle Stimulator, Model 202

San Shih Electrical Enterprise Co., Ltd., Hsin-Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071093 is the FDA 510(k) clearance record for SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202, a class II device, cleared for San Shih Electrical Enterprise Co., Ltd. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list one 510(k) clearance for San Shih Electrical Enterprise Co., Ltd. As of , FDA records show no recalls naming K071093.

Clearance record

Decision date
Received
(232 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
San Shih Electrical Enterprise Co., Ltd. # 58, Fu-Chiun St., Hsin-Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260