PMT/NerveSpa Compliance Details

	A	B	C	D	E	F	G	H	I	J	K	L
1		FDA Establishment Registration Database		https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=43437
2
3		PMT Device Listings
4	Listing Number	Proprietary Name	Confidential Flag	Owner Operator Number	Listing Number	Premarket Submission Number	Premarket Exception	Product Code	Device Name	Registration Number	Activities	Database Link
5	D130238	NerveSpa Shoulder Pro	N	9002150	D130238	K073386		NYN	Stimulator, electrical, transcutaneous, for arthritis	1528161	Complaint File Establishment	Link to FDA 510(k) Database
6	D245954	Thermotech Heating Pad	N	9002150	D245954		510(k) Exempt	IRT	PAD, HEATING, POWERED	1528161	Complaint File Establishment	510k Exempt
7	D262660	NerveSpa Classic	N	9002150	D262660	K143430		NUH	STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER	1528161	Complaint File Establishment	Link to FDA 510(k) Database
8	D262730	SOFT TOUCH	N	9002150	D262730	K142099		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
9	D575100	NerveSpa Pro	N	9002150	D575100	K140168		NUH	STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER	1528161	Complaint File Establishment	Link to FDA 510(k) Database
10	D575100	NerveSpa Dual	N	9002150	D575100	K140168		NUH	STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER	1528161	Complaint File Establishment	Link to FDA 510(k) Database
11	D575105	EGlove	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
12	D575105	EASleeve	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
13	D575105	ECuff	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
14	D575105	CR2000	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
15	D575105	ESock	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
16	D575105	EVest	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
17	D575105	Dusleeve	N	9002150	D575105	K103719		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
18	D575107	Infarex	N	9002150	D575107	K140865		ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	Link to FDA 510(k) Database
19	D575107	Theralamp	N	9002150	D575107	K140865		ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	Link to FDA 510(k) Database
20	D575109	Power Wrap	N	9002150	D575109		510(k) Exempt	ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	510k Exempt
21	D575118	Brightwand	N	9002150	D575118	K132643		FTC	LIGHT, ULTRAVIOLET, DERMATOLOGICAL	1528161	Complaint File Establishment	Link to FDA 510(k) Database
22	D575118	Brightwand Cordless	N	9002150	D575118	K132643		FTC	LIGHT, ULTRAVIOLET, DERMATOLOGICAL	1528161	Complaint File Establishment	Link to FDA 510(k) Database
23	D575119	EE10	N	9002150	D575119	K222770		GYB	Media, electroconductive	1528161	Complaint File Establishment	Link to FDA 510(k) Database
24	D575121	SP3360	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
25	D575121	SPS2000	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
26	D575121	SPS1250	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
27	D575121	SP3000	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
28	D575121	SP2040	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
29	D575121	SP1515	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
30	D575121	SP1531	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
31	D575121	SP155	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
32	D575121	SPS2020	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
33	D575121	SP2000	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
34	D575121	SPS3000	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
35	D575121	SP1540	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
36	D575121	SPS2040	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
37	D575121	SP2020	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
38	D575121	SP1000	N	9002150	D575121	K030375		GXY	Electrode, cutaneous	1528161	Complaint File Establishment	Link to FDA 510(k) Database
39	D575273	Stim3	N	9002150	D575273	K024036		IPF	Stimulator, muscle, powered	1528161	Complaint File Establishment	Link to FDA 510(k) Database
40				9002150	D575273	K024036		LIH	Interferential current therapy	1528161	Complaint File Establishment	Link to FDA 510(k) Database
41	D575273	R3500	N	9002150	D575273	K024036		IPF	Stimulator, muscle, powered	1528161	Complaint File Establishment	Link to FDA 510(k) Database
42				9002150	D575273	K024036		LIH	Interferential current therapy	1528161	Complaint File Establishment	Link to FDA 510(k) Database
43	D575274	DIGIGAL	N	9002150	D575274	K032994		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
44	D575275	U5	N	9002150	D575275	K040253		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
45	D575275	U20	N	9002150	D575275	K040253		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
46	D575277	UCombo	N	9002150	D575277	K050921		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
47				9002150	D575277	K050921		IPF	Stimulator, muscle, powered	1528161	Complaint File Establishment	Link to FDA 510(k) Database
48	D575277	UStim	N	9002150	D575277	K050921		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
49				9002150	D575277	K050921		IPF	Stimulator, muscle, powered	1528161	Complaint File Establishment	Link to FDA 510(k) Database
50	D575278	IFC4000D	N	9002150	D575278	K072256		ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	Link to FDA 510(k) Database
51				9002150	D575278	K072256		LIH	Interferential current therapy	1528161	Complaint File Establishment	Link to FDA 510(k) Database
52				9002150	D575278	K072256		PFW	Stationary ultrasonic diathermy device for use in applying therapeutic deep heat	1528161	Complaint File Establishment	Link to FDA 510(k) Database
53	D575279	PM2000	N	9002150	D575279	K092627		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
54				9002150	D575279	K092627		IMG	Stimulator, ultrasound and muscle, for use in applying therapeutic deep heat	1528161	Complaint File Establishment	Link to FDA 510(k) Database
55	D575280	IF4000	N	9002150	D575280	K093138		GZJ	Stimulator, nerve, transcutaneous, for pain relief	1528161	Complaint File Establishment	Link to FDA 510(k) Database
56				9002150	D575280	K093138		IPF	Stimulator, muscle, powered	1528161	Complaint File Establishment	Link to FDA 510(k) Database
57				9002150	D575280	K093138		LIH	Interferential current therapy	1528161	Complaint File Establishment	Link to FDA 510(k) Database
58	D575281	MJC10	N	9002150	D575281	K201196		INI	VEHICLE, MOTORIZED 3-WHEELED	1528161	Complaint File Establishment	Link to FDA 510(k) Database
59	D575282	SC100	N	9002150	D575282	K211263		NGX	Stimulator, muscle, powered, for muscle conditioning	1528161	Complaint File Establishment	Link to FDA 510(k) Database
60				9002150	D575282	K211263		NUH	STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER	1528161	Complaint File Establishment	Link to FDA 510(k) Database
61	D575345	Quake Plate Vibration Plate	N	9002150	D575345		510(k) Exempt	ISA	Massager, therapeutic, electric	1528161	Complaint File Establishment	510k Exempt
62	E233022	Aqua Relief System (AIS/ARS)	N	9002150	E233022		510(k) Exempt	ILO	Pack, hot or cold, water circulating	1528161	Complaint File Establishment	510k Exempt
63	D575109	NerveBeam Red Light Wrap	N	9002150	D575109		510(k) Exempt	ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	510k Exempt
64	D575109	NerveBeam Cold Laser	N	9002150	D575109		510(k) Exempt	ILY	Lamp, infrared, therapeutic heating	1528161	Complaint File Establishment	510k Exempt
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