510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851037Substantially Equivalent for Some Indications

Orthotron Muscle Stimulator Mk II Dc

Hodgkinson & Corby, Ltd., Henley-On-Thames/England, GB / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K851037 is the FDA 510(k) clearance record for ORTHOTRON MUSCLE STIMULATOR MK II DC, a class II device, cleared for Hodgkinson & Corby , Ltd. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list one 510(k) clearance for Hodgkinson & Corby , Ltd. As of , FDA records show no recalls naming K851037.

Clearance record

Decision date
Received
(97 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Hodgkinson & Corby , Ltd. Raymar, Henley-On-Thames/England, GB
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