510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921351Substantially Equivalent

Jace Model Pm-410 Hand Cpm Device

Jace Systems, Inc., Moorestown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921351 is the FDA 510(k) clearance record for JACE MODEL PM-410 HAND CPM DEVICE, a class I device, cleared for Jace Systems, Inc. on under FDA product code JFA (Exerciser, Finger, Powered). FDA records list 6 510(k) clearances for Jace Systems, Inc., from to . As of , FDA records show no recalls naming K921351.

Clearance record

Decision date
Received
(46 days to decision)
Product code
JFA Exerciser, Finger, Powered
Regulation
21 CFR 890.5410
Device class
Class I
Review panel
Physical Medicine
Applicant
Jace Systems, Inc. 101 Foster Rd., Moorestown NJ
510(k) summary
Statement
Third party review
No

Clearances, product code JFA

Trailing 12 months

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

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