Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - BioWave Corporation

Address:

8 Knight St Suite 201 Norwalk CT 06851

Norwalk

CT 06851

United States

Authorised Representative/ UK Responsible Person
Name: P14 Medical Ltd
Address:

65 Bath Road

Stroud

Gloucestershire GL5 3LA

England United Kingdom

Code/Term Type

Electrode conductive skin pad reusable Electrode conductive skin pad reusable Class I

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Class IIa

Analgesic PENS system probe single-use Analgesic PENS system probe single-use Class IIa

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Class IIa

Transcutaneous electrical stimulation electrode reusable Transcutaneous electrical stimulation electrode reusable Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Electrode conductive skin pad reusable	Electrode conductive skin pad reusable	Class I
Physical therapy transcutaneous neuromuscular electrical stimulation system	Physical therapy transcutaneous neuromuscular electrical stimulation system	Class IIa
Analgesic PENS system probe single-use	Analgesic PENS system probe single-use	Class IIa
Analgesic transcutaneous electrical nerve stimulation system	Analgesic transcutaneous electrical nerve stimulation system	Class IIa
Transcutaneous electrical stimulation electrode reusable	Transcutaneous electrical stimulation electrode reusable	Class I