# K091248: Maxems, Models 1000 and 2000

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Nov 30, 2009 after 216 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010665 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072795: Models Ems 5.0, Ems 5.1, Koalaty Products, Inc. (2007) Summary page 1.
- K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems, Everyway Medical Instruments Co.,Ltd (2002) Summary page 1.

## Indications for use
1. Relax muscles 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis 6. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K091248
Methodology: https://510kreport.com/methodology