Question 1

What types of medical devices does TENS Plus Industrial Company manufacture?

Accepted Answer

TENS Plus Industrial Company specializes in devices for pain relief and therapeutic massage, including cupping therapy tools, static magnetic massagers, reusable instrument trays, and moxibustion containers. Their portfolio also covers external manual massagers for clinical use, transcutaneous electrical stimulation (TENS) leads, and full TENS systems designed for analgesic treatment. These products cater to both professional healthcare settings and consumer use.

Question 2

Where is TENS Plus Industrial Company based?

Accepted Answer

The company is headquartered in Hong Kong. This location allows them to operate within a global regulatory environment while focusing on manufacturing devices that align with international standards for medical and therapeutic applications.

Question 3

Which regulatory registries list TENS Plus Industrial Company’s devices?

Accepted Answer

The company’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for their products under relevant regulatory frameworks.

Question 4

How are TENS Plus Industrial Company’s devices classified under medical regulations?

Accepted Answer

The company’s devices fall into Class I, Class II, and Unclassified (U) categories. Classification depends on factors like risk level, intended use, and potential patient exposure. For example, reusable instrument trays may qualify as Class I due to low risk, while TENS systems—due to their electrical stimulation—could be classified as Class II or Unclassified depending on specific design and safety features.

Question 5

What is the primary purpose of TENS Plus Industrial Company’s TENS systems and related devices?

Accepted Answer

The TENS systems and transcutaneous electrical stimulation leads produced by the company are designed for analgesic treatment, delivering controlled electrical impulses to nerve pathways to relieve pain. These devices are often used in clinical and consumer settings for managing chronic or acute pain, such as muscle soreness, arthritis, or postoperative discomfort.

Device	Model / Reference	Registries	Class	Status
Pole Electrode Pen Type	A4.Pen	FDA UDI	Class I	Active
Rolling Drum Gold Color	"Drum.Mini.8 "	FDA UDI	Class I	Active
Tsun.Meter	BD2361	FDA UDI	Class II	Active
Bio-North Flex Magnet 4x6"	Bio.N.Sheet	FDA UDI	Class I	Active
Sili Massage Cup 7.0cm L (pair)	"Cup.Sil.Lg "	FDA UDI	Class I	Active
Massage Rod 9cm	Guasha.R.A	FDA UDI	Class I	Active
Ring.Finger	MY2602	FDA UDI	Class I	Active
Connecting Wire To Duck Beak Clip Adaptor	Micro.Duck	FDA UDI	Class II	Active
Magnet Sheet Square 9x5mm	"Multi.Card "	FDA UDI	Class I	Active
Hoki Needle Short	Shoni.Hoki	FDA UDI	Class I	Active
Ins.MP.S	MD2611	FDA UDI	Class I	Active
Lion.Warm.XL	GY5336	FDA UDI	Class I	Active
Plastic Cup 2.8cm, 2pc/Pkt	"Cup.SD5 "	FDA UDI	Class I	Active
Vitality Smokeless Moxa Roll	Roll.Vital	FDA UDI	Class I	Active
Choto-Sword Shaped Shonishin	Shoni.Choto	FDA UDI	Class I	Active
Ins.MP.M	MD2612	FDA UDI	Class I	Active
Vaccaria 50-C Press	Vaccar.50	FDA UDI	Class I	Active
Jade Massage Blade Heart	Gua.Jd.Ht	FDA UDI	Class I	Active
Guasha.S	BY2608	FDA UDI	Class I	Active
Cup G Triangle For Dy2110	"Cup.Long.Tr "	FDA UDI	Class I	Active
Cup.Long.xD	DY0444	FDA UDI	Class I	Active
E-Stim II	ED3922	FDA UDI	Class II	Active
Moxa Punk 100gm/Pkt	Moxa.Yomei	FDA UDI	Class I	Active
Flex Magnet Round5cm( 2")	Multi.D.2	FDA UDI	Class I	Active
Metal Tray 11x3.5x1cm	Saucer.S	FDA UDI	Class I	Active
E-Stim III	ED3981	FDA UDI	Class II	Active
Heragata-Arrow Shape Shonishin	Shoni.Hera	FDA UDI	Class I	Active
Multi.D.1.5	MD2802	FDA UDI	Class I	Active
Moxa.Bx.BamL	GY5338	FDA UDI	Class I	Active
Jumbo Roller	Drum.Jumbo	FDA UDI	Class I	Active
Ins.MP.L	MD2613	FDA UDI	Class I	Active
Vaccaria 600-T	Vaccar.600	FDA UDI	Class I	Active
Yoneyama Copper	Shoni.Yone.C	FDA UDI	Class I	Active
Cup N Stim 3cm	Cup.Stim.3	EUDAMEDFDA UDI	Class I	Active
Glass Cup Flat Top No.4	FireCup.4X	EUDAMEDFDA UDI	Class I	Active
Pestle Needles	Pestle.Set	EUDAMEDFDA UDI	Class I	Active
Pump.Sq.M	WY4964	EUDAMEDFDA UDI	Class I	Active
Longevity Smokeless Sticks W Hole (new Box)	Roll.Longev	FDA UDI	Class I	Active
"Pump.Sq.Sm "	WY4963	FDA UDI	Class I	Active
Moxa Rolls, Dia. 6mm 30pc/Pkt	Hand.P.7	FDA UDI	Class I	Active
Md4493 3.5mm Tinsel Pin Lead	Wire.3.5	FDA UDI	Class II	Active
Magnetic Hair Brush	Hair.Brush	FDA UDI	Class I	Active
Metal Tray 13.8x6.6x1.8cm	Saucer.M	EUDAMEDFDA UDI	Class I	Active
Moxa Punk 11001-3, 100gm /pkt	Moxa.Sup.B	EUDAMEDFDA UDI	Class I	Active
Awq-104l	ED3923	FDA UDI	Class II	Active
Cup F 1.6cm For Dy2110	"Cup.Long.xF "	FDA UDI	Class I	Active
Pointer Pal	Pt.Pal	EUDAMEDFDA UDI	Class II	Active
E-S III Allig Wire	Estim.W.Bl Brow Rd Yell	FDA UDI	Class II	Active
Pump N Cup 3cm	Cup.Pump.3	FDA UDI	Class I	Active
Large Roller W/E-Jack	Drum.Large	FDA UDI	Class I	Active

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