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
Pump N Cup 5cm	Cup.Pump.5	EUDAMEDFDA UDI	Class I	Active
Tiger.Warm.S	GY5367	FDA UDI	Class I	Active
Dual Probe 9.8 Mm (3-7/8 ")	Dual.Probe	EUDAMEDFDA UDI	Class I	Active
Axus Es-5	ED3930	FDA UDI	U	Active
Massage Rod 12.5cm	Guasha.R.12	FDA UDI	Class I	Active
Jade Massage Blade Rect.	"Gua.Jd.Rec "	EUDAMEDFDA UDI	Class I	Active
Matsuba-Pine Brush Shonishoin	Shoni.Matsu	FDA UDI	Class I	Active
Tiger.Warm.S	GY5367	FDA UDI	Class I	Active
Pulse Pad Large Size	Pulse.Pad.L	FDA UDI	Class I	Active
Pure Moxa Sticks/500 Pcs	"Mini.500 "	FDA UDI	Class I	Active
Tsubo.Vib	MY2750	FDA UDI	Class I	Active
Moxa Punk Golden 11001-1b	Moxa.Sup.A	FDA UDI	Class I	Active
Guasha.L	BY2610	FDA UDI	Class I	Active
Sili Massage Cup 5.5cm S (pair)	"Cup.Sil.Std "	FDA UDI	Class I	Active
Pure Gold Soft Moxa 50gm /bag	Moxa.L.PGSM	FDA UDI	Class I	Active
Search+stim Probe Axus Es-5	Axus.x.Probe	EUDAMEDFDA UDI	U	Active
Spring Probe W/ Magnet	Ion.Shin	FDA UDI	Class I	Active
Ion Pumping Cord	Allig.Pin	FDA UDI	Class II	Active
Cy2441 Connecting Wire Banana Plug	Banana.3.5	FDA UDI	Class II	Active
Magnetic Needles, 3000 Gauss	Mag.Probe.3G	EUDAMEDFDA UDI	Class I	Active
Srolling Tiger Warmer Chrom	Lion.Warm.S	EUDAMEDFDA UDI	Class I	Active
Pump N Cup 4cm	Cup.Pump.4	FDA UDI	Class I	Active
Moxa Roll 4mm (30pcs/Box)	Hand.P.1	FDA UDI	Class I	Active
Surgical Tray	"OpenTray.4 "	FDA UDI	Class I	Active
Pump.Sq.L	WY4965	FDA UDI	Class I	Active
Pistol.Long	DY2111	EUDAMEDFDA UDI	Class I	Active
Smokeless Small Size Moxa Stick	Hand.P.4.S	FDA UDI	Class I	Active
Spring Auricular Needle	Tei.Shin	EUDAMEDFDA UDI	Class I	Active
Cup N Stim 4.5cm	Cup.Stim.4	EUDAMEDFDA UDI	Class I	Active
Rect. Shape W/ Finger Arch	Guasha.Arch	FDA UDI	Class I	Active
Plastic Cup 5.0cm, 2pc/Pkt	"Cup.SD1 "	FDA UDI	Class I	Active
Ultra Pure Soft Moxa 50gm /bag	Moxa.L.UPSF	FDA UDI	Class I	Active
Glass Cups Flat Top Set (1, 2, 3	FireCup.Set	EUDAMEDFDA UDI	Class I	Active
Cup A 5.7cm For Dy2110	"Cup.Long.xA "	FDA UDI	Class I	Active
Pure Moxa Punk 250gm/Pkt	Moxa.Crude	FDA UDI	Class I	Active
Star-22 Magnetic Balls	"Star.22 "	FDA UDI	Class I	Active
S.s.salve Pot M244 Dia.8x8cm	"Jar.SS.Med "	FDA UDI	Class I	Active
Smokeless Moxa Rolls, Dia. 6mm	Hand.P.8.S	EUDAMEDFDA UDI	Class I	Active
Pointer Plus - Hand Pole	PtP.Ground	EUDAMEDFDA UDI	Class I	Active
Massage Rod 9cm	Guasha.R.9	FDA UDI	Class I	Active
*** Pointer Excel - Probe	Pt.Exx.Grd	EUDAMEDFDA UDI	Class I	Active
RECT. SHAPE 10 x 5.5CM (L)	Guasha.L	FDA UDI	Class I	Active
Cup J Curved 2.7cm For Dy2110	Cup.Long.MC	FDA UDI	Class I	Active
Bachi-Bari Shonishin	Shoni.Bachi	FDA UDI	Class I	Active
Plastic Cup 2.3cm, 2pc/Pkt	"Cup.SD6 "	FDA UDI	Class I	Active
Ip-2 Ion Pumping Kit	Ion.IP2	FDA UDI	Class I	Active
Massage Rod 11cm	Guasha.R.S	FDA UDI	Class I	Active
Moxi Rolls (ti)	"Roll.Tai.I "	FDA UDI	Class I	Active
Dual Facial Probe	Face.Probe	FDA UDI	Class I	Active
Gb-3	GD5208	FDA UDI	Class II	Active

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