SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT— 510(k) K902719
Substantially EquivalentLabeltape Meditect, Inc.
FDA 510(k) clearance K902719 for SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT, Substantially Equivalent on 1990-07-19. Applicant: Labeltape Meditect, Inc.. Device class: 2.
Clearance details
- Applicant
- Labeltape Meditect, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Recent devices under product code GXY
view all- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Labeltape Meditect, Inc.
view all- K951328 — LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD
- K915333 — ELECTRODE USING PROMEON RG-60 SERIES GEL
- K914871 — TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
- K912979 — HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
- K902738 — ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
Data sourced from openFDA. This site is unofficial and independent of the FDA.