# K210166: Omnispec ED1000

- Pathway: 510(k) (Traditional)
- Applicant: Medispec, Ltd.
- Decided: Jan 27, 2023 after 736 days
- Product code: ISA (Massager, Therapeutic, Electric)
- Device class: 1
- Regulation: 21 CFR 890.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 193 ancestors in all.
No later device cites it as a predicate yet.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210451: OrthoGold 100, Tissue Regeneration Technologies, LLC (2021). Cleared while this submission was under review Summary page 4.
- K173692: D-Actor 200 Vibration Massage System, Storz Medical AG (2018) Summary page 4.

## Indications for use
The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Source page: https://510kreport.com/device/K210166
Methodology: https://510kreport.com/methodology