Were fully worn female urinary-incontinence stimulators exempt prosthetic devices?

Plain-English summary

The product combined an externally worn electrical neuromuscular stimulator with a removable vaginal electrode. It caused contractions of the pelvic muscles and urinary sphincter to treat incontinence.

California distinguished the device from a TENS pain-relief unit and treated it as a prosthetic device because it assisted the sphincter in its natural function of retaining and releasing urine. Furnishing the product was exempt if the complete device was fully worn on or in the body and supplied under a licensed physician's written order.

Common questions

Was the device exempt because it resembled a TENS unit?

No. The opinion expressly rejected that comparison and applied the prosthetic-device definition instead.

Did the exemption apply without a physician's written order?

No under the stated analysis.

What assumptions mattered?

The opinion assumed the Liberty and Innova products worked the same way and that the complete device was fully worn on or in the user's body.

Citations and references

• 18 Cal. Code Regs. § 1591(b)(5) — prosthetic devices assisting a natural body part
• 18 Cal. Code Regs. § 1591(i) — qualifying furnishing conditions

Source

• Annotated Legal Opinions collection: https://cdtfa.ca.gov/taxes-and-fees/annotations-menu.htm
• Annotation page: https://cdtfa.ca.gov/lawguides/vol2/suta/425-0000-all.html
• Original supporting opinion: https://cdtfa.ca.gov/lawguides/annotations/425-0907.pdf

Original ruling text

State of California

Board of Equalization

Memorandum

To:

David H. Levine

From:

John L. Waid

Subject:

Annotation Section 425.0000(b)
Specific Items Classified

425.0907

Date:

October 4, 1996

Attached hereto please find a copy of my recent letter to X---------------------, regarding female urinary incontinence products. They likened these items to TENS devices. It is not our policy to expand the TENS exemption beyond the specific facts of the TENS device itself. The item at issue did qualify as a straight-ahead prosthetic device. As a result, I suggest annotation of this letter to emphasize the distinction between the two. I suggest the following language: "Urinary Incontinence Products (Female). The Innova female urinary incontinence product causes involuntary contractions of the pelvic musculature and urinary sphincter in order to treat or cure incontinence. This device is composed of an externally worn, microprocessor-based electrical neuromuscular stimulator that activates a tampon-like vaginal electrode worn internally. We conclude from this description that while these devices are not akin to TENS units they do qualify as prosthetic devices if they are fully worn on the body of the user. Typically, a TENS unit is designed to relieve pain through the use of electrical impulses which are emitted from the unit directly to the area of the body in which the patient is experiencing pain. By contrast, the female urinary incontinence device appears to assist the vaginal sphincter in performing its natural function--staying closed in order to retain urine, and opening to evacuate the bladder under the control of the patient. This use fits precisely the regulatory definition. The Liberty Female Urinary Incontinence Product, if fully worn on the body of the user, is thus a prosthetic device within the meaning of Regulation 1591(b) (5) with the result that furnishing such products to patients pursuant to the written order of a licensed physician is not subject to tax. (Reg. 1591 (i) .)"

JLW:cl

425.0907

STATE OF CALIFORNIA

STATE BOARD OF EQUALIZATION
LEGAL DIVISION – MIC: 85
450 N STREET, SACRAMENTO, CALIFORNIA
PO BOX 942879, SACRAMENTO, CALIFORNIA 94279-0082
TELEPHONE (916) 324-2655
FAX (916) 323-3387

JOHAN KLEHS
First District, Hayward
DEAN ANDAL
Second District, Stockton
ERNEST J. DRONENBURG, JR.
Third District, San Diego
BRAD SHERMAN
Fourth District, Los Angeles
KATHLEEN CONNELL
Controller, Sacramento

E. L. SORENSEN, JR
Executive Director

October 4, 1996

[No Permit Number]
Liberty Feminine Urinary
Incontinence Product
Dear X---------------------,
I am responding to your letter dated August 2, 1996, to Executive Director E. L. Sorensen, Jr. You ask for advice that Utah Medical's sales of the Liberty Feminine Urinary Incontinence Product are not subject to tax. You attached to your letter a partial copy of a letter on Board letterhead from which the date and taxpayer information have been excised; the signature page is also missing. The author of that letter likened the device at issue therein, the Innova Female Urinary Incontinence Product, to a Transcutaneous Electrical Nerve Stimulator (TENS) and cited Annotations 425.0885 (11/15/77 & 4/11/83) and 425.0247.5 (3/14/90) for authority that such devices are considered prosthetic devices the sales of which are exempt from tax when the device is furnished pursuant to the written order of a licensed physician. You state that Utah Medical's product is equivalent to the Innova product. The letter attached to your letter terms the Innova "an electro-therapeutic device used by a patient for in-home treatment of incontinence" and describes its operation as follows: "The Innova causes involuntary contractions of the pelvic musculature and urinary sphincter in order to treat or cure incontinence. This device is composed of an externally worn, microprocessor-based electrical neuromuscular stimulator that activates a tamponlike vaginal electrode worn internally." We presume from your statement that the Liberty product works the same way and has the same components as does the Innova device. We also assume that the "tampon-like vaginal electrode" is not implanted and may be removed at any time. The device seems to be fully worn on the body of the user. OPINION:

Regulation 1591 provides, in part, as follows:
"(b)

The term "medicines" means and includes:
*

*

*

(5)
Prosthetic devices, or their replacement parts, designed to be worn on or in the person of the user to replace or assist the functioning of a natural part of the human body, other than auditory, ophthalmic and ocular devices or appliances, and other than dentures, removable or fixed bridges, crowns, caps, inlays, artificial teeth and other dental prosthetic materials and devices." From the description you provide, we are of the opinion that these devices are not akin to TENS units for the purposes of this analysis. However, we conclude that they do qualify as prosthetic devices. Typically, a TENS unit is designed to relieve pain through the use of electrical impulses which are emitted from the unit directly to the area of the body in which the patient is experiencing pain. By contrast, the female urinary incontinence device appears to assist the vaginal sphincter in performing its natural function – staying closed in order to retain urine, and opening to void the bladder under the control of the patient. This use fits precisely the regulatory definition. The Liberty Female Urinary Incontinence Product is thus a prosthetic device within the meaning of Regulation 1591 (b) (5) 'with the result that furnishing such products to patients pursuant to the written order of a licensed physician is not subject to tax. (Reg. 1591 (i) .) I hope the above discussion has answered your question. If you need anything further, please do not hesitate to write again. Sincerely,

John L. Waid
Senior Tax Counsel
JLW:sr
Cc:

Ms. Rosie Ornelas-Odarte (MIC:40)