510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062631Substantially Equivalent

Myomo E100

Myomo, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062631 is the FDA 510(k) clearance record for MYOMO E100, a class II device, cleared for Myomo, Inc. on under FDA product code OAL (Exercise Equipment, Powered, Emg-Triggered). FDA's definition for product code OAL reads: "To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education". FDA records list one 510(k) clearance for Myomo, Inc. As of , FDA records show no recalls naming K062631.

Clearance record

Decision date
Received
(219 days to decision)
Product code
OAL Exercise Equipment, Powered, Emg-Triggered
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Myomo, Inc. 529 Main St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAL

Trailing 12 months

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

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