# K212832: TimeWaver Frequency

- Pathway: 510(k) (Traditional)
- Applicant: Timewaver Production GmbH
- Decided: Dec 14, 2021 after 98 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: 6 generations back to K010335 (2001). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator, Cymedica Orthopedics, Inc. (2015) Summary page 4.

## Most influential descendants
- K240992: eMVFit (MVF-10M) (2024), 0 descendants of its own

## Indications for use
As an NMES device, indications are for the following conditions: -Relaxation of muscle spasms -Retardation or prevention of disuse atrophy -Increased local blood circulation -Re-Educating muscles -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis -Maintaining or increasing range of motion. As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic intractable pain -Adjunctive treatment for post-surgical and post-traumatic acute pain

Source page: https://510kreport.com/device/K212832
Methodology: https://510kreport.com/methodology