← Product Code [IPL](/productcode/IPL) · K030882

# RABBIT MOBILE STANDING FRAME (K030882)

_R82 A/S · IPL · Apr 4, 2003 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K030882

## Device Facts

- **Applicant:** R82 A/S
- **Product Code:** [IPL](/productcode/IPL.md)
- **Decision Date:** Apr 4, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3900
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to stand, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is utilized during incremental weight bearing for a child who has good head, neck, and upper body control, and is utilized by a child that is capable of standing of their own volition, but requires support and alignment in weight bearing.

## Device Story

Rabbit Mobile Standing Frame is a mobile transport and standing aid for children; provides anterior support from feet to sternum; facilitates incremental weight bearing from prone to upright positions. Device used in clinical or home settings; operated by child with assistance from caregiver/physician. Supports children with sufficient head/neck/upper body control who can stand voluntarily but need alignment. Benefits include improved weight-bearing posture and mobility.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Mobile standing frame; provides anterior support from feet to sternum; mechanical design for incremental weight bearing from prone to upright; no electronic components or software.

## Regulatory Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

## Submission Summary (Full Text)

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APR 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R82 A/S c/o Mr. Kirk MacKenzie Snug Seat, Inc. 12801 East Independence Boulevard Stallings, NC 28105

Re: K030882

Trade/Device Name: Rabbit Mobile Standing Frame Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: March 19, 2003 Received: March 20, 2003

Dear Mr. MacKenzie:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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## Page 2 - Mr. Kirk MacKenzie

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mulhern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

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for Mark A. Milken

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO30882 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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**Source:** [https://fda-staging.innolitics.com/device/K030882](https://fda-staging.innolitics.com/device/K030882)

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