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
Moxa Tools	GD5250	EUDAMED	Class I	Active
Massage Tools	CD4398	EUDAMED	Class I	Active
Trays and containers	HY7217	EUDAMED	Class I	Active
Vacuum cupping and Tools	DP2398	EUDAMED	Class I	Active
Massage Tools	CD4383	EUDAMED	Class I	Active
Moxa Tools	GP5515	EUDAMED	Class I	Active
Vacuum cupping and Tools	DY2159	EUDAMED	Class I	Active
Moxa Tools	GY5222	EUDAMED	Class I	Active
Vacuum cupping and Tools	DY2136	EUDAMED	Class I	Active
Moxa Tools	GD5221	EUDAMED	Class I	Active
Massage Tools	BS2285	EUDAMED	Class I	Active
Vacuum cupping and Tools	DT2386	EUDAMED	Class I	Active
Vacuum cupping and Tools	DY2158	EUDAMED	Class I	Active
Vacuum cupping and Tools	DP0458	EUDAMED	Class I	Active
Vacuum cupping and Tools	DY2132	EUDAMED	Class I	Active
Moxa Tools	GY5225	EUDAMED	Class I	Active
Gua Sha and Massage Tools	MY2650	EUDAMED	Class I	Active
Vacuum cupping and Tools	DP2396	EUDAMED	Class I	Active
Choki Shoni-Shin	Shoni.Choki	FDA UDI	Class I	Active
Cup I Curved 3.5cm For Dy2110	"Cup.Long.LC "	FDA UDI	Class I	Active
Roller, Silver Colour	Drum.Round	EUDAMEDFDA UDI	Class I	Active
Guasha.M	BY2609	FDA UDI	Class I	Active
Moxi Rolls (ny)	Roll.Nien.Y	FDA UDI	Class I	Active
Cup N Stim 6cm	Cup.Stim.6	FDA UDI	Class I	Active
Ear Magnets W/P-100	"Ear.Dot.EZ "	EUDAMEDFDA UDI	Class I	Active
Dual Head Jade Roller 14.5cm	Roller.Jade	FDA UDI	Class I	Active
Pistol	DY0950	FDA UDI	Class I	Active
Moxa.Bx.BamS	GY5337	EUDAMEDFDA UDI	Class I	Active
Glass Cupping Set (14 Pcs/Set)	Cup.LO.Glas	FDA UDI	Class I	Active
Bio.N.2	MD2863	FDA UDI	Class I	Active
Medium Grade Moxa 50gm/Bag	Moxa.L.MGM	FDA UDI	Class I	Active
Pointer-Plus	ED3332	FDA UDI	Class II	Active
RECT. SHAPE 8X4.8cm (M)	Guasha.M	FDA UDI	Class I	Active
Glass Cup Flat Top No.1	FireCup.1S	EUDAMEDFDA UDI	Class I	Active
Cup C 3.6cm For Dy2110	"Cup.Long.xC "	FDA UDI	Class I	Active
Longevity Brand Cupping Set W/16 Cups & Pump	Cup.Long.16	FDA UDI	Class I	Active
Lrolling Tiger Warmer Chrom	Lion.Warm.L	FDA UDI	Class I	Active
Pulse Pad	Pulse.Pad	FDA UDI	Class I	Active
Pointer Excel II	ED3988	FDA UDI	Class II	Active
Cup B 4.8cm For Dy2110	"Cup.Long.xB "	FDA UDI	Class I	Active
Glass Cup Flat Top No.2	FireCup.2M	EUDAMEDFDA UDI	Class I	Active
Cup E 1.9cm For Dy2110	"Cup.Long.xE "	FDA UDI	Class I	Active
Massager Blade Fish Shape	Guasha.Shar	EUDAMEDFDA UDI	Class I	Active
Point Mate	Point.Mate	EUDAMEDFDA UDI	Class II	Active
Plastic Cup 4.5cm, 2pc/Pkt	"Cup.SD2 "	FDA UDI	Class I	Active
Pump N Cup 2cm	Cup.Pump.2	EUDAMEDFDA UDI	Class I	Active
Glass Cup Flat Top No.3	FireCup.3L	EUDAMEDFDA UDI	Class I	Active
Pole Electrode Pen Type	PtP.Probe	FDA UDI	Class I	Active
Sili Massage Facial Cup (pair)	"Cup.Sil.El "	FDA UDI	Class I	Active
Pump N Cup 5cm	Cup.Pump.5	EUDAMEDFDA UDI	Class I	Active

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