← Product Code [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI) · K101611

# RELAY POWER WHEELCHAIR (K101611)

_Dalton Instrument Corp. · ITI · Sep 29, 2010 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K101611

## Device Facts

- **Applicant:** Dalton Instrument Corp.
- **Product Code:** [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI.md)
- **Decision Date:** Sep 29, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3860
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## Indications for Use

The intended use of the Relay is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

## Device Story

Relay is a powered wheelchair designed to provide mobility to individuals with physical limitations requiring a seated position. Device operates via user-controlled inputs to drive electric motors, facilitating independent movement. Intended for use by patients capable of operating the controls. Output is physical mobility for the user. Device is used in various environments where wheelchair access is appropriate.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Powered wheelchair; Class II; Product Code ITI; 21 CFR 890.3860.

## Regulatory Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

## Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dalton Instrument Corporation % Ms. Jennifer Yu 3788 Arapaho Road Addison, Texas 750001 .

Re: K101611

Trade/Device Name: Relay Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 4, 2010 Received: August 4, 2010

SEP 2 9 2010

Dear Ms. Yu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Ms. Jennifer Yu

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## |(101611

## Indications for Use

SEP 2 9 2010

510(k) Number (if known):

ಿಗೆ ಮಾಡಿದ್ದಾರೆ. ಇದರ ಕಾರಿ ನಿರ್ದೇಶನ ಸಂದರ್ಭದ ಪ್ರಕಾರಿಗೆ ಸರ್ವಾಟಕದ ಬಾರಿಗೆ ಸರ್ವಾರದ ಮತ್ತು ಅವರು ಅವರು ಅ

Device Name: Relay

Indications For Use:

The intended use of the Relay is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Prescription Use (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K101611](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K101611)

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