# K062631: Myomo E100

- Pathway: 510(k) (Traditional)
- Applicant: Myomo, Inc.
- Decided: Apr 12, 2007 after 219 days
- Product code: OAL (Exercise Equipment, Powered, Emg-Triggered)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012885 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042650: Biomove 3000, Curatronic, Ltd. (2005) Summary page 1.
- (no number) Kinetec 6080 CPM for Elbow: named in the summary without a submission number
- (no number) Boston Digital Arm System: named in the summary without a submission number

## Indications for use
The Myomo el 00 is indicated for use by stroke patients urr rehabilitation to facilitate the following: • Stroke rehabilitation by muscle re-education • Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K062631
Methodology: https://510kreport.com/methodology