POINTER PLUS

Stimulator, Nerve, Transcutaneous, For Pain Relief

LHASA OMS, INC.

The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Pointer Plus.

Pre-market Notification Details

Device IDK060508
510k NumberK060508
Device Name:POINTER PLUS
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
ContactMark W Sheehan
CorrespondentMark W Sheehan
LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-27
Decision Date2006-06-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14897076720047 K060508 000

Trademark Results [POINTER PLUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POINTER PLUS
POINTER PLUS
78354414 not registered Dead/Abandoned
Peachtel USA, Inc.
2004-01-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.