510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051357Substantially Equivalent

Ds7a Constant Current High Voltage Stimulator, Model Ds7a; Ds7ah Constant Current High Voltage Stimulator, Model Ds7ah

Digitimer Ltd., Fort Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051357 is the FDA 510(k) clearance record for DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH, a class II device, cleared for Digitimer , Ltd. on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list 2 510(k) clearances for Digitimer , Ltd., from to . As of , FDA records show no recalls naming K051357.

Clearance record

Decision date
Received
(119 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Digitimer , Ltd. One E. Broward Blvd., Suite 700, Fort Lauderdale FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWF

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