510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153163Substantially Equivalent

ReGrasp

Rehabtronics, Inc., Edmonton, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K153163 is the FDA 510(k) clearance record for ReGrasp, a class II device, cleared for Rehabtronics, Inc. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 2 510(k) clearances for Rehabtronics, Inc., from to . As of , FDA records show no recalls naming K153163.

Clearance record

Decision date
Received
(157 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Rehabtronics, Inc. #4532, 10230 Jasper Ave., Edmonton, CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZI

Trailing 12 months

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

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