# Labeltape Meditect, Inc.

- Location (FDA's records): Grand Rapids, MI
- FDA decisions: 26 (1986–1995): 26 510(k) clearances
- Product codes: DRX (10), GXY (9), KHE (2), DXN (1), GEI (1), DXH (1), GZJ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ampcare, LLC: 1 (https://510kreport.com/company/ampcare)
- Pain Management Technologies: 1 (https://510kreport.com/company/pain-management-technologies)
- Uni-Patch, Inc.: 1 (https://510kreport.com/company/uni-patch)

## Its most-cited devices
- K915333: Electrode Using Promeon RG-60 Series Gel (1992), cited by 2
- K894042: Spect.E.N.S. Repositionable, Pin Type, Tens (1989), cited by 1

## Recent decisions
- K951328: Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord (Apr 25, 1995)
- K915333: Electrode Using Promeon RG-60 Series Gel (Jan 14, 1992)
- K914871: Trans Elec Nerve Stim/Muscle Stim Elec W/Poly Gel (Dec 18, 1991)
- K912979: Hemawipe System, the Civilized Test, Modification (Oct 4, 1991)
- K902738: Electro Blue Ecg Electrode-Pediatric Cloth (Sep 4, 1990)
- K902719: Spect.E.N.S. Repostion.-E Foam Pin Type Tens Elect (Jul 19, 1990)
- K900656: Spec T.E.N.S. Prewired Repositionable Tens Elect. (Mar 1, 1990)
- K896844: Babe-Ease Neonatal Cloth Ecg Electrode (Feb 12, 1990)

Source page: https://510kreport.com/company/labeltape-meditect