510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875103Substantially Equivalent

Bio-Feedback Limb Monitor Type Code Bl-34-1

Shield Computers, Ltd., Barnsley S70 1ll, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875103 is the FDA 510(k) clearance record for BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1, a class I device, cleared for Shield Computers , Ltd. on under FDA product code IKE (Transducer, Miniature Pressure). FDA records list one 510(k) clearance for Shield Computers , Ltd. As of , FDA records show no recalls naming K875103.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IKE Transducer, Miniature Pressure
Regulation
21 CFR 890.1615
Device class
Class I
Review panel
Physical Medicine
Applicant
Shield Computers , Ltd. John St., Barnsley S70 1ll, GB
Third party review
No

Clearances, product code IKE

Trailing 12 months

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

FDA records show no clearances under product code IKE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKE, 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