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

Exercise Equipment, Powered, Emg-Triggered

21 CFR 890.1375 / Physical Medicine
FDA source (opens on fda.gov)

OAL is the FDA product code for Exercise Equipment, Powered, Emg-Triggered, a class II device type, regulated under 21 CFR 890.1375. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OAL
Device name
Exercise Equipment, Powered, Emg-Triggered
FDA definition
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.
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OAL

By decision year
1 clearance under product code OAL with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OAL by decision year
YearClearances
20071

Applicants with the most clearances

Product code OAL
Applicants holding the most 510(k) clearances under product code OAL
ApplicantClearances
Myomo, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OAL.